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# MMS Holdings: Data CRO | Global Clinical Research & Health Data Analytics Company

## Sitemaps
[XML Sitemap](https://mmsholdings.com/sitemap_index.xml): Includes all crawlable and indexable pages.

## News
- [MMS Highlights Expanded West Coast Biotech Engagement Ahead of BIO International Convention 2026](https://mmsholdings.com/mms-holdings-west-coast-biotech-bio-2026/): Canton, Michigan — MMS Holdings, a global, data-focused clinical research organization (CRO), today highlighted its expanded engagement with emerging and growth-stage biotech and biopharma companies across the U.S. West Coast ahead of the BIO International Convention 2026.
- [MMS Strengthens Science-Led Global Leadership, Naming Ben Dudley as President ](https://mmsholdings.com/mms-names-ben-dudley-president-global-leadership/): (CANTON, MICHIGAN and LONDON). MMS Holdings, a global, data-focused clinical research organization (CRO), today named UK-based Ben Dudley as President, extending his existing role as Chief Commercial Officer. The expanded position further supports MMS’ vision and growth as a science-led CRO, helping sponsors worldwide navigate complexity, reduce risk, and advance clinical programs through its integrated biometrics and regulatory capabilities. Dudley’s appointment reinforces MMS’ increasing international presence and builds on strong recent momentum in Europe, including the 2025 acquisition of Exploristics, a Belfast-based biostatistics and data science company.  
- [MMS Appoints FDA Alum Dr. Somya Dunn as Senior Medical Director, Safety Risk Management to Expand Leadership in REMS and Pharmacovigilance Solutions ](https://mmsholdings.com/mms-appoints-fda-alum-dr-somya-dunn-as-senior-medical-director-safety-risk-management/): CANTON, Mich. (February 5, 2026) – MMS, a global, data-focused clinical research organization (CRO), today announced that Somya Dunn, MD, has joined the company as Senior Medical Director, Safety Risk Management, further advancing the company’s leadership in risk-benefit assessments for submissions, pharmacovigilance and Risk Evaluation and Mitigation Strategies (REMS). 
- [Datacise® by MMS Named Finalist for Innovation in the Management of Clinical Data at the 2026 ACDM Awards ](https://mmsholdings.com/mms-acdm-2026-awards-datacise-finalist/): CANTON, Mich. (January 29, 2026) – MMS, a global, data-focused clinical research organization (CRO), today announced it has been named a finalist in the 2026 Association for Clinical Data Management (ACDM) Awards for Innovation in the Management of Clinical Data in recognition of Datacise®, its secure, cloud-based clinical data science platform. 
- [Former FDA, CRO, and Industry Leader Dr. Stephine Keeton Joins MMS as Senior Director of Biometrics ](https://mmsholdings.com/stephine-keeton-joins-mms-biometrics/): CANTON, Mich. (December 4, 2025) – MMS, a global, data-focused clinical research organization (CRO), announced today that Stephine Keeton, PhD, has joined the company as Senior Director of Biometrics. Her appointment comes against an industry backdrop of rising trial and data complexity, alongside intensifying pressure on sponsors to accelerate cycle times and enhance productivity. With experience spanning regulatory, biopharma, and CRO environments, Dr. Keeton is uniquely positioned to strengthen MMS’ specialist biometrics capabilities and support sponsors in addressing today’s expanding clinical data challenges. Immediately prior to joining MMS, she led biostatistics at Altimmune, a clinical-stage biopharmaceutical company, and has previously served within the FDA in statistical roles for more than seven years. 
- [MMS Brings Biometrics and AI Leadership to PHUSE EU Connect 2025 and Previews Accepted Presentations for US Connect 2026](https://mmsholdings.com/mms-phuse-2025-2026/): CANTON, Mich. and HAMBURG (November 14, 2025) – MMS, a global, data-focused clinical research organization (CRO), is set to bring fresh insights and hands-on engagement to PHUSE EU Connect 2025, taking place in Hamburg, Germany, from November 16-19, 2025, at CCH - Congress Center Hamburg.
- [MMS Named Finalist in the Fierce Life Sciences Innovation Awards for KerusCloud® Clinical Trial Simulation Platform ](https://mmsholdings.com/mms-fierce-innovation-keruscloud/): CANTON, Mich. and BELFAST (October 16, 2025) – MMS, a global, data-focused clinical research organization (CRO), announced today that it has been named a finalist in the 2025 Fierce Innovation Awards: Life Sciences Edition for its clinical trial simulation platform, KerusCloud®. Recognized as one of the top solutions in the Data Analytics and Business Intelligence category, KerusCloud® has successfully demonstrated a powerful, data-driven impact by making clinical trial design more cost-effective, efficient, and scientifically robust, accelerating development across therapeutic areas.   
- [MMS Announces Its Role in Supporting Gates Ventures and the GNPC to Deliver One of the World’s Largest Proteomic Datasets for Neurodegenerative Diseases](https://mmsholdings.com/mms-supports-gates-ventures-gnpc-delivering-proteomic-dataset/): Global neurodegenerative disease research advances through harmonized data from over 20 international cohorts
- [MMS Named Finalist in Citeline’s 2025 Scrip Awards for Best Contract Research Organization (CRO) – Specialist Providers ](https://mmsholdings.com/mms-named-finalist-in-citelines-2025-scrip-awards-for-best-contract-research-organization-cro-specialist-providers/): Canton, Michigan, USA (September 25, 2025) – MMS, a global, data-focused clinical research organization (CRO), announced today that it has been named to the 2025 Scrip Awards shortlist for Best Contract Research Organization – Specialist Providers. Powered by Citeline, a Norstella Company, and hosted in London, UK, this honor recognizes CROs that play a critical role in accelerating drug development through focused, high-quality clinical research support and regulatory services. 
- [Friends of Cancer Research and MMS Collaborate to Develop Decision Frameworks for Interim Overall Survival Data in Oncology Trials](https://mmsholdings.com/mms-friends-cancer-research-oncology-os-framework/): CANTON, Mich. and WASHINGTON, D.C. (August 19, 2025) – MMS, a global, data-focused clinical research organization (CRO), announced today that it has been chosen by Friends of Cancer Research (Friends), a leading nonprofit dedicated to accelerating innovation in cancer research, to support the development of practical decision frameworks to inform the interpretation of interim overall survival (OS) data in oncology clinical trials.
- [MMS Wins in the 2025 Fierce CRO Awards for Excellence in Client Service and Partnership and Dr. Uma Sharma Named CRO Champion ](https://mmsholdings.com/mms-2025-fierce-cro-awards-client-service-leadership/): CANTON (June 19, 2025) – MMS, a global, data-focused clinical research organization (CRO), has been named the winner of the 2025 Fierce CRO Award in the category of Excellence in Client Service and Partnership and the company’s CEO Dr. Uma Sharma has earned the CRO Champion Award, which recognizes leaders whose vision and values have shaped the future of clinical development.
- [MMS Named Finalist for Fierce CRO Award in Excellence in Client Service and Partnership, CEO shortlisted for the CRO Champion Award ](https://mmsholdings.com/mms-named-finalist-for-fierce-cro-award-in-excellence-in-client-service-and-partnership-ceo-shortlisted-for-the-cro-champion-award/): CANTON, Mich. (May 28, 2025) – MMS, a global, data-focused clinical research organization (CRO), has been named a finalist in the 2025 Fierce CRO Awards in the category of Excellence in Client Service and Partnership. Judged on the ability of MMS to demonstrate innovation and impact, measurable outcomes, and scalability, MMS stood out as one of the top three organizations with a strong commitment to building collaborative, long-term sponsor relationships. 
- [Datacise by MMS Wins 2025 Data Breakthrough Award for Best Data Science Solution](https://mmsholdings.com/datacise-by-mms-wins-2025-data-breakthrough-award-for-best-data-science-solution/): CANTON, Mich. (April 3, 2025) — MMS, an award-winning, data-focused Contract Research Organization (CRO), today announces that its innovative Datacise® platform has been named the Overall Data Science Solution of the Year in the 2025 Data Breakthrough Awards. Datacise is an innovative, cloud-based technology platform that enables biotechnology and pharmaceutical companies to more efficiently curate, analyze, and visualize clinical and real-world data to accelerate decision-making.  
- [MMS REMS-focused Technology bolsters Full-Service REMS Solutions](https://mmsholdings.com/full-service-rems-solutions/): For nearly two decades, MMS has been a trusted partner in regulatory strategy, data science, and regulatory writing, helping life sciences companies achieve compliance and approval success. This latest tech-enabled real-time evaluation of safety with REMS solutions builds on that legacy, ensuring that sponsors have the following support:
- [MMS Acquires Exploristics and KerusCloud Simulation Platform to Expand Biostatistics and Data Science Capabilities as a Global Data-Focused CRO](https://mmsholdings.com/mms-acquires-exploristics-keruscloud/): CANTON, Mich. (February 12, 2025) – MMS, an award-winning, data-focused clinical research organization (CRO), announced today its acquisition of Exploristics, a leading biostatistics and data science company based in Belfast, Northern Ireland. The acquisition will add the company’s flagship product, KerusCloud®, a state-of-the-art, cloud-based statistical modeling and simulation platform to MMS’ data-driven approach towards efficient drug development.
- [AI in Pharma and Innovative Leadership Were on Display at the Biennial MMS Scientific Symposium](https://mmsholdings.com/ai-pharma-leadership-symposium/): The Biennial Scientific Symposium at MMS is a global opportunity to bring together leading minds from within the CRO and across the industry to explore the intersection of artificial intelligence (AI) in pharma, innovative trial designs, and leadership in a tech-enabled world. Over the course of four days, thought leaders, scientists, and industry experts shared cutting-edge insights, practical applications, and forward-thinking strategies aimed at transforming the future of clinical trials.
- [MMS Recognized as a Top Workplace by Detroit Free Press and USA Today Network for the Fourth Consecutive Year](https://mmsholdings.com/mms-top-workplace-2024-detroit-free-press/): DETROIT (November 19, 2024) – MMS, a leading data and regulatory focused clinical research organization (CRO), today announced its recognition as a Top Workplace by the Detroit Free Press and the USA Today Network for the fourth consecutive year. This prestigious award is based entirely on employee feedback, highlighting the company’s unwavering commitment to fostering a positive and engaging work environment.
- [MMS Named a Finalist in the 2024 Fierce CRO Awards for Leadership in Regulatory Compliance](https://mmsholdings.com/mms-fierce-cro-awards-2024-regulatory-compliance/): CANTON, Mich. (November 8, 2024) – MMS, a leading data and regulatory focused clinical research organization (CRO), today announced that its regulatory team has been selected as one of three top finalists in the Fierce CRO Awards for Leadership in Regulatory Compliance.
- [MMS Recognized with EcoVadis Bronze Medal for Leadership in ESG Sustainability Efforts as a Leading Clinical Research Organization (CRO)](https://mmsholdings.com/ecovadis-bronze-medal-leadership-esg-sustainability/): CANTON, Mich. (October 15, 2024) – MMS, a leading data and regulatory focused clinical research organization (CRO), today announced that it has been awarded bronze medal status by EcoVadis, demonstrating its commitment to environmental, social, and governance (ESG) initiatives. Bronze medal status is earned by organizations that are in the top 35th  percentile globally when scored against criteria across a variety of environmental, ethical, social and sustainability factors.
- [Industry Veteran Ben Dudley Joins MMS as Chief Commercial Officer (CCO) to Drive Continued Growth for the Data-focused Clinical Research Organization](https://mmsholdings.com/ben-dudley-joins-mms-cco/): CANTON, Mich. and READING, UK (July 17, 2024) – MMS, a data-focused clinical research organization (CRO), announced today that Ben Dudley has been appointed as the company’s new Chief Commercial Officer (CCO). Based in the UK, Ben Dudley brings more than 25 years of life sciences expertise on the CRO and Sponsor side, holding previous operational and commercial leadership roles at Parexel, Covance, and AstraZeneca.
- [MMS Hires Pharmaceutical Industry Veteran James Zee for Global Biometrics Leadership in Europe Amid Strong Regional Growth](https://mmsholdings.com/mms-hires-james-zee-european-biometrics/): CANTON, Michigan, and LONDON (April 4, 2024) – MMS, a leading, data-focused clinical research organization (CRO), announced today that the company has expanded its biometrics leadership within European operations by hiring James Zee as Director of Global Statistical Programming. Based in the United Kingdom (UK), Zee brings 25 years of experience across several leading pharmaceutical companies, including AstraZeneca, MSD, Novartis, Roche, and others.
- [MMS Holdings Inc – A Data-Centric CRO Powerhouse Reshaping Drug Development on a Global Scale](https://mmsholdings.com/mms-holdings-data-centric-cro-drug-development/): Canton, Mich. (March 5, 2024) –MMS Holdings Inc, a distinguished global Clinical Research Organization (CRO), stands at the forefront of supporting pharmaceutical and biotech companies, along with numerous smaller enterprises, across a comprehensive range of services. With an impressive track record of successfully completing over 50 submissions for drug approval in the past five years, MMS has solidified its position as the preferred choice for sponsors seeking innovation and unwavering quality from their CRO partners.
- [MMS Supported Lykos Therapeutics: NDA Submitted to FDA for First Psychedelic-Assisted Therapy for PTSD](https://mmsholdings.com/maps-pbc-nda-submission-ptsd-therapy-mdma/): Canton, Mich. (December 13, 2023) – MMS, a data-focused Clinical Research Organization (CRO), announced Lykos Therapeutics, formerly known as MAPS Public Benefit Corporation (MAPS PBC) submitted a New Drug Application (NDA) to the FDA for MDMA (midomafetamine capsules) used in combination with psychological intervention, which includes psychotherapy, or talk therapy, and other supportive services provided by a qualified healthcare provider. MAPS PBC is developing investigational MDMA-assisted therapy for individuals with post-traumatic stress disorder (PTSD). Over a year ago, MAPS PBC selected MMS as its CRO partner for the development of NDA for MDMA-assisted therapy for PTSD. If approved, MDMA-assisted therapy could be the first psychedelic-assisted therapy.
- [MMS Named Great Place to Work in the UK as Growth in the Region Doubles](https://mmsholdings.com/mms-named-great-place-to-work-in-the-uk/): “We are proud to be certified as a Great Place to Work in the UK,” said Chris Schoonmaker, Chief Operating Officer, MMS. “Our growing number of UK colleagues exemplify our mission and core values, and their contributions to our global team has helped us be successful as an organization and advance life changing therapies to help patients and families worldwide. We plan to expand and grow in the UK and Europe to build on our teams and deliver value to our clients”
- [MMS Scientific Advisory Board’s New Members Expand CRO’s Therapeutic Expertise](https://mmsholdings.com/mms-scientific-advisory-boards-new-members-expand-cros-therapeutic-expertise/): CANTON, Mich. (March 21, 2023) – MMS Holdings, an award-winning, data-focused CRO, announced today the addition of Dr. Philip Breitfeld and Dr. Bernhardt Zeiher to its board of scientific advisors. Both industry leaders in innovative clinical trial delivery solutions, Dr. Breitfeld and Dr. Zeiher’s additions as advisors expand MMS’ therapeutic area expertise to support growth in different therapeutic areas.
- [MMS Partners with I-ACT to Advance Children’s Clinical Trials](https://mmsholdings.com/mms-partners-with-i-act-to-advance-childrens-clinical-trials/): CANTON, Mich. (February 21, 2023) – MMS, a data-focused contract research organization (CRO) – announced its partnership with the Institute for Advanced Clinical Trials (I-ACT) to accelerate the development of life-saving therapeutics including vaccines, medicines, and medical devices for children.
- [Award-Winning Data CRO Expands Executive Leadership to Support Company’s Next Stage of Growth](https://mmsholdings.com/award-winning-data-cro-expands-executive-leadership-to-support-companys-next-stage-of-growth/): CANTON, Mich. (2/7/2023) – MMS Holdings (MMS) – an award-winning, data-focused contract research organization (CRO) – announces the expansion of its leadership team with the appointment of Chris Schoonmaker as Chief Operating Officer. This comes as the company was recognized in the 2023 Top Workplace USA awards, a national list of organizations with strong company cultures and high employee satisfaction rates, and a Great Place to Work in India.
- [MMS Named a Great Place to Work in India](https://mmsholdings.com/mms-named-a-great-place-to-work-in-india/): BANGALORE, India (1/12/2023) – MMS Holdings, a data-focused contract research organization (CRO), has been named a Great Place to Work by the Great Place to Work Institute of India.
- [MMS Named Michigan Top Workplace For The Second Consecutive Year](https://mmsholdings.com/mms-named-michigan-top-workplace-for-the-second-consecutive-year/): CANTON, Mich. (11/21/2022) – MMS Holdings, a data-focused contract research organization (CRO), has been named a 2022 award winner of the Michigan Top Workplaces by the Detroit Free Press Top Workplaces. This is the second year that MMS has been recognized with this honor.
- [Together Trial with EDC Database Designed by MMS Wins Trial of the Year](https://mmsholdings.com/together-trial-with-edc-database-designed-by-mms-wins-trial-of-the-year/): The TOGETHER Trial, which uses an Electronic Data Capture (EDC database) system designed, built, and maintained by MMS Holdings, a data-focused contract research organization (CRO), won the Society for Clinical Trial’s annual Trial of the Year Award for 2021.
- [MMS Holdings Partners with Lindsay Goldberg for Its Next Stage of Growth](https://mmsholdings.com/mms-holdings-partners-with-lindsay-goldberg-for-its-next-stage-of-growth/): MMS Holdings Inc. (“MMS” or the “Company”), a leading data-focused contract research organization (“CRO”), today announced that Lindsay Goldberg, a leading family and founder-focused private equity firm, has completed an investment in the Company alongside MMS Founder and CEO, Dr. Uma Sharma, who will maintain a significant ownership interest. The partnership will help MMS expand its award-winning services to pharma and biotech companies and extend MMS’ leadership in data-focused clinical research services
- [Novel PTSD Treatment Advances Toward Regulatory Evaluation with New Collaboration Between MAPS PBC and MMS Holdings](https://mmsholdings.com/novel-ptsd-treatment-advances-toward-regulatory-evaluation-with-new-collaboration-between-maps-pbc-and-mms-holdings/): MMS Holdings (MMS), an award-winning, data-focused contract research organization (CRO), announced today that it has been selected by MAPS Public Benefit Corporation (MAPS PBC) as its contract research organization for the development of a New Drug Application (NDA) for MDMA-assisted therapy for posttraumatic stress disorder (PTSD). This announcement comes on PTSD Awareness Day as the confirmatory Phase 3 trial MAPP2, the second of two Phase 3 trials conducted by MAPS PBC, finished enrollment in early May. 
- [MMS Holdings Announces Partnership with Medidata to Provide Medidata’s Advanced Rave EDC and Decentralized Clinical Trial Solutions to Sponsors](https://mmsholdings.com/mms-holdings-announces-partnership-with-medidata-to-provide-medidatas-advanced-rave-edc-and-decentralized-clinical-trial-solutions-to-sponsors/): MMS Holdings, a data-focused Contract Research Organization (CRO), is pleased to announce a strategic partnership with Medidata, a Dassault Systèmes company, to provide clients a full range of solutions for clinical data management (CDM) and decentralized clinical trial solutions (DCTs), including Medidata’s unified platform and Rave EDC (Electronic Data Capture).
- [MMS Holdings Selects THREAD as Partner of Choice to Deliver Decentralized Clinical Trials](https://mmsholdings.com/mms-holdings-selects-thread-as-partner-of-choice-to-deliver-decentralized-clinical-trials/): MMS Holdings Inc. (MMS) – an award-winning, data-focused contract research organization (CRO) – announced a collaboration with THREAD® as its partner of choice for its decentralized clinical trials platform (DCT) and DCT-enabled services. THREAD’s next-generation DCT technology enables faster, more efficient clinical trials while improving access for research participants with higher quality data capture across the life cycle of a study.
- [Senior Biopharma Executive Joins MMS Holdings as Principal Medical Director](https://mmsholdings.com/senior-biopharma-executive-joins-mms-holdings-as-principal-medical-director/): MMS Holdings, a data-focused contract research organization (CRO), announced the addition of Robert Allen, MD, biopharma executive, as Principal Medical Director of Global Drug Safety and Pharmacovigilance to its team.
- [MMS Holdings Only Michigan Pharma Organization Awarded a 2022 Top Workplace USA Recognition](https://mmsholdings.com/mms-holdings-only-michigan-pharma-organization-awarded-a-2022-top-workplace-usa-recognition/): CANTON, Mich. (2/2/2022) - MMS Holdings, a Data CRO, was recognized in the 2022 Top Workplace USA awards, a national list of organizations with strong company cultures and high employee satisfaction rates.  MMS, a minority and woman-owned business in Canton, was the only Michigan Pharma organization on the national list.
- [MMS Strengthens Leadership in the Area of Project Advisory Services](https://mmsholdings.com/mms-strengthens-leadership-in-the-area-of-project-advisory-services/): MMS Holdings announced a restructuring of their consulting services with the launch of a Project Advisory Services Unit to meet the needs of many small to mid-sized organizations in immediate, short and long-term needs for senior-level guidance, specialized consulting, and advisory services.
- [MMS Holdings Wins 2021 Scrip Award for Best Contract Research Organization](https://mmsholdings.com/mms-holdings-wins-2021-scrip-award-for-best-contract-research-organization/): MMS Holdings is pleased to announce its selection as Best Contract Research Organization – Specialist Providers in the 2021 Scrip Awards. The Scrip Awards, held annually by London-based Informa Pharma Intelligence, honors outstanding achievements of organizations in the pharmaceutical, biotech and allied industries.
- [Former Astellas VP of Biostatistics Joins MMS as Principal Advisor of Biostatistics](https://mmsholdings.com/former-astellas-pharma-vp-of-biostatistics-joins-mms-as-principal-advisor-of-biostatistics/): Former Astellas Pharma VP of Biostatistics Joins MMS as Principal Advisor of Biostatistics and Submissions Planning. Dr. Chartier has held positions at Astellas Pharma, Novartis, Wyeth, Pfizer, and United BioSource Corporation across various statistics, biometrics, and biostatistics functions.
- [MMS Holdings is the Winner of The Michigan Top Workplaces 2021 Award](https://mmsholdings.com/detroit-free-press-names-mms-a-winner-of-the-michigan-top-workplaces-2021-award/): CANTON, Mich. (11/15/2021) – MMS has been named a 2021 award winner of the Michigan Top Workplaces by the Detroit Free Press Top Workplaces. The award is based solely on employee feedback from an anonymous survey measuring 15 culture drivers that are critical to the success of any organization, including alignment, execution, and connection, among others.
- [Praxis bioresearch seeks support from MMS for Alzheimers Disease Therapeutics](https://mmsholdings.com/praxis-bioresearch-seeks-support-from-mms-for-alzheimers-disease-therapeutics/): MMS Holdings provided regulatory strategy support to Praxis Bioresearch in the development of a therapeutic for apathy in Alzheimer’s disease. This comes as Praxis was awarded a $2.9 Million Fast-Track SBIR Grant to advance the company’s lead development candidate PRX-P4-003.
- [MMS SmartStart™ Tech-Enabled Solution Eases Document Content Creation Process](https://mmsholdings.com/mms-holdings-announced-the-release-of-smartstart-tech-enabled-clinical-trial-templates/): MMS Holdings announced the release of SmartStart™ a Tech-Enabled Templates to reduce time and effort in the document content creation process while increasing the quality of deliverables.
- [Pro-Bono Ultra-rare Disease Regulatory Assistance Program Created By MMS for Patient Advocacy Groups](https://mmsholdings.com/pro-bono-ultra-rare-disease-regulatory-assistance-program-created-by-mms/): MMS announced today the launch of its pro-bono support program aimed at advancing research for ultra-rare diseases. Within this program, MMS will select from patient advocacy groups with demonstrable need and will provide complimentary regulatory assistance.
- [Data CRO Expands its Virtual Learning Portfolio](https://mmsholdings.com/data-cro-expands-its-virtual-learning-portfolio/): MMS announced that its learning arm, MMS Academy, has expanded its global training portfolio with the launch of new courses in inspection readiness and clinical programming. These new courses – created by industry-trained subject matter experts – will give students and working professionals the opportunity to gain the critical knowledge that the pharmaceutical, biotechnology, and medical device industries require.
- [MMS Poised for an Innovative Future with Best Clinical Research Organization Award and Two Key Executive Appointments](https://mmsholdings.com/mms-poised-for-an-innovative-future-with-best-clinical-research-organization-award-and-two-key-executive-appointments/): MMS announced the growth of its leadership team with the appointment of Kelly J. Hill to Executive Vice President (EVP) of Global Business Operations and Strategy and Michelle Gayari to Executive Vice President of Global Operational Excellence and Innovation. This comes as the company was awarded Best Data-Focused Biotech CRO in the International Life Sciences Awards.
- [Health Data Research UK Selects MMS as Data Services Partner for the International COVID-19 Data Alliance](https://mmsholdings.com/health-data-research-uk-selects-mms-as-data-services-partner-for-the-international-covid-19-data-alliance/): MMS has been selected by Health Data Research UK (HDR UK) – the national institute for health data science – as a partner to support the International COVID-19 Data Alliance (ICODA) initiative. MMS was selected from a pool of some of the world’s top clinical research organizations to provide data engineering services to support a globally coordinated, health data-led research response to tackle the COVID-19 pandemic.
- [MMS Holdings Joins DTRA as A Founding Member to Accelerate The Adoption of Patient- Focused](https://mmsholdings.com/mms-holdings-joins-decentralized-trials-research-alliance-dtra-as-a-founding-member-to-accelerate-the-adoption-of-patient-focused-clinical-trials/): MMS Holdings – an award-winning, data-focused CRO – joins a historic alliance of fifty life sciences and healthcare organizations that seeks to accelerate the broad adoption of patient-focused, decentralized clinical trials and research.
- [MMS Academy Launches Mobile App for Accessing Pharmaceutical Industry Virtual Learning Courses from Anywhere](https://mmsholdings.com/mms-academy-launches-mobile-app-for-accessing-pharmaceutical-industry-virtual-learning-courses-from-anywhere/): CANTON, Mich. (October 28, 2020) – MMS Holdings (MMS) – an award-winning, data-focused CRO – announced today that its learning arm, MMS Academy, now offers access to all of its virtual pharmaceutical industry courses through a mobile smart device application. As an innovative convenience, students and working professionals can access course material anytime, anywhere across the globe.

## Pages
- [Meet MMS at PSI 2026](https://mmsholdings.com/meet-mms-at-psi-2026/): With KerusCloud®, you get data-backed insights that accelerate development, reduce costs, and increase the probability of trial success. Please fill in the form below to book your slot at PSI 2026.
- [Clinical Development in Europe](https://mmsholdings.com/european-clinical-development/): European clinical development requires more than adapting a US strategy for a different region. Sponsors navigating EMA, MHRA, and wider European requirements need development, biometrics, and regulatory expertise built around the realities of European programs from the outset.
- [REMS Solutions ](https://mmsholdings.com/solutions/rems-solutions/): MMS delivers full-service REMS solutions that integrate proprietary technology, deep regulatory expertise, and overall program management to support sponsors across design, implementation, optimization, and lifecycle management of REMS programs. Our integrated approach combines regulatory and safety expertise, real-time data visibility, and highly responsive support to help sponsors of all sizes meet US FDA expectations and maintain patient access. 
- [20 Year Landing page](https://mmsholdings.com/mms-20-years-data-led-drug-development/): MMS was founded on people and purpose. For 20 years, we’ve focused on scientific excellence, data-led decisions, and genuine partnership because getting the evidence right is what ultimately gets therapies to patients.
- [Fact Sheets](https://mmsholdings.com/fact-sheets-2/)
- [Ebooks](https://mmsholdings.com/ebooks/)
- [Whitepapers](https://mmsholdings.com/whitepapers-2/)
- [Case Studies](https://mmsholdings.com/case-studies-2/)
- [Expedited Regulatory Pathways](https://mmsholdings.com/services/expedited-regulatory-pathways/): Expedited regulatory pathways offer sponsors the opportunity to bring promising therapies to patients faster, but navigating these routes requires strategic planning, early engagement, and a clear understanding of regulatory expectations.
- [Whitepapers](https://mmsholdings.com/whitepapers/)
- [Fact Sheets](https://mmsholdings.com/fact-sheets/)
- [Case Studies](https://mmsholdings.com/case-studies/)
- [Exploristics](https://mmsholdings.com/exploristics/): Exploristics, the Northern Ireland-based biostatistics and data science company, has officially joined MMS. This integration includes KerusCloud®, a leading trial simulation platform that strengthens our ability to support complex development programs.
- [Data Monitoring Committees (DMCs)](https://mmsholdings.com/services/data-monitoring-committees/): At MMS, we understand the critical role that Data Monitoring Committees (DMCs) play in safeguarding participants and maintaining the scientific integrity of clinical trials. As a core component of our biometrics services, we offer end-to-end DMC support tailored to meet regulatory expectations and trial complexity—ensuring trials stay on track, compliant, and data-driven. 
- [The Chief Medical Officer’s Investor Playbook](https://mmsholdings.com/cmo-investor-playbook/): This new eBook, The Chief Medical Officer’s Investor Playbook: Leveraging Biostatistics to Boost Fundraising Confidence, provides actionable insights to help CMOs and biotech executives de-risk their programs, build investor trust, and secure funding faster. Drawing on MMS expertise, this guide reveals strategies you can apply right now to strengthen your pitch and clinical development plan.
- [Psychedelics](https://mmsholdings.com/solutions/psychedelics/): Psychedelic therapies offer real potential, but also come with unique development hurdles. From subjective endpoints and high-risk patient dynamics to a shifting regulatory landscape, success in this space demands deep, specialist experience.
- [Strategic Consulting](https://mmsholdings.com/solutions/strategic-consulting-solutions/): MMS Strategic Consulting brings together regulatory strategy, statistical consulting, and data expertise to support critical decisions across the drug development lifecycle. These consulting services combine regulatory strategy, statistical consulting and data expertise to help Sponsors make confident, evidence-based decisions that reduce risk and improve outcomes.
- [Expert Medical Writing Support](https://mmsholdings.com/expert-medical-writing-support/): In today’s fast-paced clinical environment, delays in documentation can derail timelines. Whether you're facing a sudden spike in workload, internal turnover, or a need for specialized expertise, MMS offers agile medical writing capacity that scales with your needs.
- [Unlock Insights from DIA 2025](https://mmsholdings.com/oncology-innovations-neurology-infectious-rare-disease-trials-dia-2025/): At DIA 2025, MMS thought leaders Margaret Studzinska and Ritchie Patton presented their latest research during Poster Session II. Now, you can access the full poster and learn how adaptive trial design methodologies, biomarker-driven strategies, and accelerated development pathways pioneered in oncology are being applied to complex trials and research in other therapeutic areas.
- [Solving for complexity ebook](https://mmsholdings.com/solving-for-complexity-clinical-trial-data-strategies-ebook/): From adaptive designs and decentralized models to multi-vendor ecosystems and evolving regulatory expectations, today’s clinical trials are anything but simple. And while complexity is inevitable, confusion and delays don’t have to be. 
- [Statistical Consulting](https://mmsholdings.com/services/statistical-consulting-services/): At MMS, our Clinical Statistical Consulting Services are designed to go beyond analysis. We bring partnership, foresight, and innovation to every stage of your clinical development journey. Our consultants provide the clarity, technical expertise, and technology-enabled solutions needed to make confident, data-driven decisions that move your program forward.
- [Pulmonary Disease Specific Data Models](https://mmsholdings.com/ai-technology/keruscloud-clinical-trial-simulation/pulmonary-clinical-data-models/): KerusCloud® Pulmonary Suite equips your team with expertly curated clinical trial data models across a wide range of respiratory conditions—from COPD and IPF to asthma and RSV. Designed by our Data Science team using real-world, regulatory-grade datasets, the suite helps sponsors and researchers identify optimal endpoints, biomarkers, patient populations, and design strategies. Whether you're optimizing a Phase II study or validating assumptions for regulatory submission, KerusCloud® accelerates decision-making and reduces trial risk—before your study ever begins.
- [Synthetic Dataset Generation](https://mmsholdings.com/ai-technology/keruscloud-clinical-trial-simulation/synthetic-clinical-data-generation/): KerusCloud® offers advanced synthetic data generation for clinical research, helping teams simulate realistic patient-level datasets without compromising privacy. Whether you're designing trials, building external control arms, or training AI models, KerusCloud® enables you to generate high-quality data that mirrors real-world conditions. This empowers faster, safer decision-making—especially when access to real data is limited, sensitive, or incomplete.
- [Patient Recruitment](https://mmsholdings.com/ai-technology/keruscloud-clinical-trial-simulation/patient-recruitment-optimization/): Patient recruitment remains one of the most critical and challenging aspects of clinical trial success. With KerusCloud®, you can simulate recruitment rates, test multiple scenarios, and optimize strategies before your study begins. By bridging operational planning with statistical rigor, KerusCloud® helps you reduce recruitment delays, minimize patient burden, and increase the probability of trial success—all in silico.
- [Clinical Trial Design & Analysis](https://mmsholdings.com/ai-technology/keruscloud-clinical-trial-simulation/clinical-trial-design-analysis/): KerusCloud® is a powerful clinical trial design and analysis software that enables sponsors to simulate thousands of realistic trial scenarios in silico. By modeling variables such as patient populations, endpoints, recruitment timelines, and estimand strategies, KerusCloud® helps teams identify the optimal design before a trial begins. Fast, data-driven, and cost-effective, it empowers you to reduce risk, accelerate timelines, and increase the likelihood of success.
- [KerusCloud](https://mmsholdings.com/ai-technology/keruscloud-clinical-trial-simulation/): KerusCloud® is an advanced clinical trial simulation software that helps research teams de-risk studies by design. This cloud-based platform enables you to model and analyze thousands of virtual trial scenarios—optimizing endpoints, recruitment strategies, and estimand frameworks before a real study begins. With KerusCloud®, you get data-backed insights that accelerate development, reduce costs, and increase the probability of trial success.
- [The Regulatory Affairs Professionals Society (RAPS)](https://mmsholdings.com/raps-trial-design-panel/): We’re pleased to partner with RAPS for this engaging, in-person event focused on the evolving role of regulatory professionals in trial design strategy. Through an interactive, discussion-driven format, our expert panel will explore how collaboration between regulatory, clinical, and statistical teams can accelerate development timelines, reduce patient burden, and mitigate regulatory risk. Learn how early cross-functional alignment leads to more efficient pathways and better-informed decisions.
- [REMS eBook](https://mmsholdings.com/rems-playbook-strategies/): The landscape of drug safety is continuously evolving, and authorized under the US Food and Drug Administration (FDA) Amendments Act of 2007, the Risk Evaluation and Mitigation Strategy (REMS) Program plays a critical role in protecting patient safety by requiring targeted risk management measures for specific drugs and drug classes. These programs are implemented either during initial product approval or as post-marketing requirements when new safety concerns arise.
- [Arbor Meus](https://mmsholdings.com/arbor-meus/): Welcome to ‘Arbor Meus’ – our unique way of expressing gratitude. At MMS, we are more than just a Global Data and Regulatory CRO; we are a family of passionate individuals spread across four continents, united in our mission to positively impact lives. As we reflect on our 17-year journey, we are deeply thankful to you, our customer – for the trust and partnership.
- [Cook Book 2.0](https://mmsholdings.com/mms-cookbook-edition-2/)
- [The BeeHive Harmony](https://mmsholdings.com/the-beehive-harmony/)
- [CRO Transition & Rescue Solutions](https://mmsholdings.com/cro-transition-rescue-solutions/): We all know how quickly challenges can arise that put data integrity, compliance, and timelines at risk. Whether you are facing issues due to internal stresses or an underperforming CRO partner, one failing clinical study can jeopardize your program’s success.
- [MMS Cook Book](https://mmsholdings.com/cook-book-2021/)
- [Neuroscience Experts Insight](https://mmsholdings.com/neuroscience-experts-insight/)
- [Regulatory Strategy Consulting](https://mmsholdings.com/services/regulatory-strategy-consulting/): At MMS, our regulatory strategy consulting provides regulatory intelligence through the collection, analysis, and interpretation of publicly-available and experience-based regulatory information. We work directly with you to create an actionable regulatory strategy to support optimal progress and development.
- [Regulatory Affairs Management](https://mmsholdings.com/services/regulatory-affairs-management/): MMS regulatory strategy experts provide consulting and can be assigned as the product lead or a lead for a specific submission type, if needed.
- [Environmental, Social, and Governance (ESG) at MMS](https://mmsholdings.com/about/environmental-social-and-governance-esg-at-mms/): At MMS, our commitment to excellence extends beyond drug development. As an award-winning, data-focused CRO, we recognize our responsibility to contribute to a sustainable, ethical, and socially responsible future. Our ESG strategy is integral to our mission to positively improve patient’s lives globally, and it guides us in every aspect of our operations and partnerships. 
- [Our Values](https://mmsholdings.com/careers/careers-at-mms/)
- [MMS Benefits](https://mmsholdings.com/careers/mms-benefits/): In alignment with our mission to positively impact lives worldwide, MMS recognizes that a comprehensive benefits package is crucial to support our colleagues’ personal and financial well-being that extends to their families. As an award-winning CRO, our benefits are aimed at boosting quality of life, supporting equity and inclusion, and focusing on professional growth and development.
- [MMS Culture](https://mmsholdings.com/careers/mms-culture/): Top Five Reasons You’ll Love Working at MMS
- [FAQs](https://mmsholdings.com/careers/faqs/): Answering Your Career Queries:
- [The MMS Experience](https://mmsholdings.com/careers/the-mms-experience/): At MMS, regardless of where our colleagues are located around the world, we are one team with one purpose – to positively improve lives worldwide. #OneMMS is more than just a hashtag. It’s a promise that our organization embraces the unique strengths and experiences of colleagues, providing everyone the opportunity to fortify and grow their talents, as well as enjoy dynamic career opportunities in life sciences.
- [Psychedelic Drug Development](https://mmsholdings.com/solutions/therapeutic-expertise/psychedelic-drug-development/): Psychedelic drug development is experiencing intense and renewed interest from the pharmaceutical industry, and the potential for these therapies to target areas of urgent unmet need. Opportunities exist for prepared sponsors to take advantage of expedited approval pathways and reach the market ahead of the competition. 
- [Therapeutic Expertise](https://mmsholdings.com/solutions/therapeutic-expertise/): From industry-firsts to well-researched indications, MMS brings a wealth of specialized knowledge across therapeutic areas to ensure that your drug development programs are supported by a team that truly understands the unique challenges and opportunities presented. We are proficient in a diverse range of therapeutic areas, including rare diseases, psychedelics, oncology and radiopharmaceuticals, central nervous system (CNS) disorders, and many others. Our deep understanding of these complex indications, combined with our data-driven approach and cutting-edge technology, allows us to be your trusted partner.
- [Global Regulatory Operations](https://mmsholdings.com/services/global-regulatory-operations/): Regulatory Operations experts at MMS are skilled at managing, preparing, and submitting a diverse array of regulatory submissions to global health authorities. Our team is committed to providing Sponsors with personalized, automated, and forward-thinking end-to-end regulatory build and submission solutions by serving as an integrated extension of our Sponsor teams. Throughout the product life cycle, our validated document management systems, industry-leading electronic Common Technical Document (eCTD) publishing and validation systems, and on-the-ground support with certified teams allow for unparalleled accuracy and efficiency. MMS supports submissions in the United States, Canada, Australia, Swiss, Eurasian/Economic Union, United Kingdom, and the Gulf Cooperation Council (GCC) regions, among others.

## Perspectives
- [Don’t Veer for Deer: Why Drug Development Needs Steady Steering in the Age of AI and Real-Time Data.](https://mmsholdings.com/perspectives/drug-development-regulatory-strategy-ai-rwe-real-time-data/): That advice feels very relatable to drug development right now. 
- [How REMS Defines the Patient Journey in Psychedelic Therapies ](https://mmsholdings.com/perspectives/rems-psychedelic-therapy-patient-access-requirements/): As psychedelic therapies near regulatory decision points, the focus is shifting. Clinical efficacy remains essential but the real test is how these therapies can be delivered safely, consistently, and at scale in real-world settings. 
- [The Future of Biostatistics: Insights from Presenters at PSI 2026](https://mmsholdings.com/perspectives/psi-2026-biostatistics-conference-simulation-ai-bayesian/): Reflecting on PSI 2026, Lesedi highlighted both the scientific content and the opportunity to connect with peers across the industry.
- [AI in Regulatory Strategy: Practical Uses for Submission Readiness ](https://mmsholdings.com/perspectives/ai-in-regulatory-strategy-practical-uses-for-submission-readiness/): Artificial Intelligence (AI) is reshaping submission readiness, but the key question for sponsors is not whether to use it, but how to apply it responsibly and effectively. 
- [What Pharma Can Learn from Data Science Outside the Industry](https://mmsholdings.com/perspectives/clinical-trial-data-pipeline-manufacturing-data-science-pharma/): Clinical development is generating more data than ever before, yet many organizations still struggle to turn that data into timely, actionable insight. While other industries, such as manufacturing, logistics, and technology, have spent decades refining how they stage, validate, and operationalize data at scale, life sciences has often remained inward‑looking when it comes to data strategy.
- [Turning Real-World Data into Reliable Evidence: The Role of Data Science](https://mmsholdings.com/perspectives/real-world-evidence-data-science-methodology-clinical-development/): Real-world evidence (RWE) is becoming an increasingly important component of clinical development and decision-making. Generated from real-world data (RWD), including electronic health records, claims data, registries, and wearable devices, RWE has the potential to complement traditional clinical trials by providing insight into how therapies perform in routine practice. 
- [Beyond Data Cleaning: A Strategic Shift for Clinical Data Management under ICH E6 (R3)](https://mmsholdings.com/perspectives/ich-e6-r3-clinical-data-management-risk-based-strategy/): The completion of ICH E6 (R3) represents a significant development in clinical research, fundamentally altering the approach to defining, implementing, and maintaining quality standards. Clinical Data Management (CDM) is undergoing a major change, moving away from everyday tasks and placing greater emphasis on delivering strategic support.
- [A Statistician’s Reflection: FDA Guidance on Limiting Crossover in Oncology Studies ](https://mmsholdings.com/perspectives/fda-crossover-oncology-overall-survival-statistical-methods/): In August 2025, the FDA released draft guidance on Approaches to the Assessment of Overall Survival in Oncology Clinical Trials. Within the guidance they describe issues regarding the use and interpretation of overall survival data, particularly when the primary endpoint is progression free survival and overall survival (OS) data is immature at the time of assessment. In many Oncology studies, an important aspect of the protocol is that participants can cross-over from the control group to the experimental treatment at the point of progression or treatment failure. This design feature can make a trial more desirable to participants, improving recruitment and retention. However, it is also recognised that crossover can impact the interpretation of results because some participants receive both treatments which makes it difficult to conduct a fair comparison of the effects of one treatment versus another. This issue becomes even more challenging when a high proportion of participants cross over.  
- [From Stigma to Signal: The Executive Order, CNPV Vouchers, and What Comes Next for Psychedelics](https://mmsholdings.com/perspectives/psychedelic-therapy-fda-clinical-trial-regulatory-challenges/): The recent Executive Order, followed by the FDA’s issuance of Commissioner’s National Priority Vouchers (CNPVs), changes the pace of psychedelic drug development without lowering the bar. By compressing review timelines from the traditional 10–12 months to as little as one to two months, the agency has made regulatory acceleration tangible.
- [The FDA Drug Shortage List Signals Deeper Concerns for the US Medicine Supply Chain](https://mmsholdings.com/perspectives/fda-drug-shortage-list-us-pharmaceutical-supply-chain/): MMS Founder and CEO, Uma Sharma, shares her thoughts on the ongoing issue of drug shortages in the US.
- [Decision-Making in Early-Phase Oncology Trials: Navigating Uncertainty with Evidence Frameworks](https://mmsholdings.com/perspectives/early-phase-oncology-trial-decision-making-framework/): Early‑phase oncology development pushes sponsors to make high‑stakes decisions with small patient numbers, evolving biology, and incomplete evidence. In this Citeline‑hosted webinar, experts from clinical development, regulatory science, and statistics explored how structured decision architectures and evidence frameworks can help organizations navigate uncertainty while keeping patient impact at the center of decision‑making.
- [Four Pillars of My Success as a Clinical Trial Transparency Specialist](https://mmsholdings.com/perspectives/career-clinical-trial-transparency-specialist/): Shawn Lantz, Senior Clinical Trial Transparency Specialist at MMS, discusses their successful career in clinical trial transparency, ensuring proper trial registration and result disclosure.
- [REMS and Labeling Are Strategic Design Decisions, Not Late-Stage Add-Ons](https://mmsholdings.com/perspectives/insights-rems-labeling-strategy-drug-development/): For many sponsors, Risk Evaluation and Mitigation Strategies (REMS) and product labeling are still treated solely as late-stage regulatory requirements. They tend to come into focus once clinical data is largely locked and submission planning is underway. By that point, teams are often responding to regulatory questions rather than shaping how risk is understood and managed. 
- [AI in Pharma: Autopilot Is Not the Same as Removing the Pilot ](https://mmsholdings.com/perspectives/ai-governance-pharma-human-oversight/): While much of the current mainstream AI conversation focuses on the pace of adoption and scale of productivity gains, in regulated industries like pharma, the more consequential issue is control. Across the clinical development lifecycle, AI applications are being proposed and introduced at a rapid pace, with regulatory agencies actively exploring how AI can support elements of the regulatory process. The momentum and potential are real, but a key challenge remains in ensuring that automation enhances decision‑making without eroding governance, compliance, and human accountability. 
- [Modeling and Simulation in Clinical Trials: A Practical Approach to De-Risking Study Design](https://mmsholdings.com/perspectives/modeling-simulation-clinical-trial-design/): As trial complexity continues to grow, static design approaches become increasingly fragile. Modeling and simulation provide a more resilient framework. 
- [Integrating AI and Automation Into Clinical Trial Operations With Discipline and Transparency](https://mmsholdings.com/perspectives/ai-clinical-trial-operations-governance/): The reality today is more practical than futuristic. AI is already being used in meaningful ways across clinical development, particularly in areas that benefit from automation, pattern recognition, and workflow efficiency. The conversation is shifting from whether AI should be used to how it should be used responsibly. 
- [A Conversation with MMS Founder and CEO Dr. Uma Sharma: Building MMS: 20 Years of People-First, Data-Led Drug Development ](https://mmsholdings.com/perspectives/mms-innovation-impact-culture-20-years-drug-development/): In Part One, Dr. Sharma explored how she founded MMS for people, and to address a fundamental gap in how data is typically handled in clinical development. In Part Two, she reflects on the meaning of innovation, shares some of the company’s most meaningful moments of real-world impact and discusses the instrumental role culture has continued to play as the organization has grown. 
- [A Conversation with MMS Founder and CEO Dr. Uma Sharma: Building MMS: 20 Years of People-First, Data-Led Drug Development ](https://mmsholdings.com/perspectives/building-mms-20-years-people-first-data-led/): As MMS marks its 20-year anniversary, founder and CEO Uma Sharma, PhD, reflects on how the company began and the purpose and principles that shaped its early direction. In Part 1 of this two-part conversation, she discusses the role of scientific judgement, problem-solving, and genuine partnership in building MMS, and why those values continue to make a difference in complex drug development today. 
- [What Regulators Want to See in Surrogate Endpoints Today ](https://mmsholdings.com/perspectives/regulatory-expectations-surrogate-endpoints/): Surrogate endpoints have always played a major role in speeding up drug development, especially in oncology and rare diseases. They use early indicators to demonstrate efficacy earlier or more efficiently than can be acheived with traditional endpoints. But as these accelerated programs have become more common, regulators are looking more closely at how those early signals translate into real patient outcomes. 
- [Behind the Scenes of Global Regulatory Submission Planning is a Symphony of Collaboration ](https://mmsholdings.com/perspectives/global-regulatory-submission-planning-collaboration/): What does it really take to get a regulatory submission across the finish line? It’s more than documents and deadlines, it is a finely tuned performance built on planning, precision, and partnership. Behind every submission is a dynamic ensemble of expertise from Project Management, Biometrics, Medical Writing, and Quality Control. 
- [Making Clinical Trial Technology Work in Practice](https://mmsholdings.com/perspectives/clinical-trial-technology/): Clinical trial technology brings data together across functions, creating a shared foundation for review and decision making. However, different teams often interpret the same information through different lenses, which can slow progress. 
- [Inside Pharma and Biotech’s Shifting Landscape and the Direction Leaders Are Giving for 2026 ](https://mmsholdings.com/perspectives/pharma-biotech-outlook-2026/): The year 2025 pushed the pharma and biotech industry to rethink how science moves through drug development. Sponsors faced a challenging mix of regulatory shifts, compressed budgets, ongoing data and trial complexity, and a wave of interest in artificial intelligence (AI) that created both momentum and uncertainty.  
- [The Real Meaning of “Expedited” in Drug Development](https://mmsholdings.com/perspectives/real-meaning-of-expedited-drug-development-pathways/): Why faster pathways demand smarter planning The term expedited in drug development might suggest a simplified path. The truth is that programs like the U.S. Food and Drug Administration’s (FDA’s) Fast Track, Breakthrough Therapy, and Accelerated Approval require more preparation, coordination, and evidence than traditional review paths. These designations can dramatically shorten time to approval, but only when sponsors understand what regulators expect and build the right infrastructure to deliver it. 
- [What AI Singularity Could Mean for the Future of Clinical Biometrics ](https://mmsholdings.com/perspectives/ai-singularity-clinical-biometrics/): Artificial Intelligence (AI) has moved well beyond theoretical speculation and is now driving meaningful transformation across clinical biometrics. As the concept of “AI singularity” approaches—where machine intelligence may rival or exceed human thinking—professionals in data management, biostatistics, and statistical programming are beginning to prepare for what this could mean for their roles and workflows. 
- [The Role of AI in Transforming Medical Writing](https://mmsholdings.com/perspectives/ai-medical-writing/): Technology has always gone hand-in-hand with medical writing in the form of toolbars or tech-enabled templates. In recent years, Artificial intelligence (AI) has become commonplace in many aspects of daily life, and as such, as part of overall life sciences transformation, medical writers need to adapt to using and eventually leveraging these AI tools to improve the writing process. At our recent MMS webinar, ‘Shaping the Future of AI-Enabled Medical Writing,’ our expert panelists Lucy Sutton (Vice President of Account Management, MMS), Teresa Cesena (Executive Director of Regulatory and Medical Writing, MMS), James Newman (Director of Medical Writing, MMS), and Zach Weingarden (Director of AI Technology and Applications, TrialAssure)—shared insights on how AI is transforming medical writing, from automation and pilot implementation to ethical considerations and regulatory readiness. This blog summarizes the key takeaways from that discussion, including current uses, benefits, challenges, and what’s next for AI in medical writing. 
- [A Leader’s Guide to Developing High-Performing Clinical Data Management Teams](https://mmsholdings.com/perspectives/clinical-data-management-teams/): Clinical data management teams face a competitive market, with career growth in the Clinical Data Manager segment expected to remain steady at 31 percent through 2028, according to Zippia. For clinical trials to be successful, it’s universally understood in the pharmaceutical and biotechnology industries that they must deliver accurate, timely, and compliant data. While technology and processes play a vital role, it’s ultimately the people who turn data into meaningful outcomes.
- [4 Key Takeaways from the EMA – Health Canada Joint Review Process and Evaluation of Its Efficiency](https://mmsholdings.com/perspectives/ema-health-canada-joint-review/): The European Medicines Agency (EMA) and Health Canada (HC) now offer sponsors a joint pathway for marketing applications, streamlining the process across both agencies. This blog will discuss four key takeaways from our experience of submitting documents under the joint review option offered to one of our sponsors. It will also evaluate the EMA’s goal of achieving greater efficiency for sponsors by streamlining the separate review process required by both health authorities into one joint review.  The joint review involves one agency taking on the role as the lead reviewer and the non-leading agency’s acceptance of the outcome.
- [New Updates on Clinical Trial Transparency and Regulatory Requirements: A Comprehensive Overview ](https://mmsholdings.com/perspectives/clinical-trial-transparency-updates/): In recent years, clinical trial transparency has become a crucial element in maintaining public trust, advancing scientific knowledge, and ensuring the safety of new treatments. Regulators around the world are tightening their requirements to improve the accessibility of trial results, enhance the quality of research, and ensure that clinical studies are ethical and reproducible. This blog will explore the latest updates on clinical trial transparency and the evolving regulatory requirements that pharmaceutical companies, researchers, and healthcare professionals must adhere to. 
- [Shaping Clinical Development Through Writing: Francesca’s Journey at MMS ](https://mmsholdings.com/perspectives/career-journey-medical-writing/): In this edition of our Career Insights series, Dr. Francesca Cianfanelli’s journey is highlighted from scientific research into medical writing. After completing two postdocs, Dr. Cianfanelli discovered a love for medical writing and is now Medical Writer II at MMS. Her strong background in microbiology and skills from working in a lab environment provide a detailed understanding of projects and how it translates on a larger scale.
- [CRO Partnerships and Biotech Agility: How Smaller Sponsors Gain Speed in Clinical Development  ](https://mmsholdings.com/perspectives/cro-biotech-agility/): Partnership with the right CRO can create this agility. When collaboration works as an extension of the sponsor’s team, the result is a model that adapts quickly, responds to change, and makes the most of both scientific vision and operational discipline. 
- [From Academia to Building Medical Writing Partnerships: Jessica Murdock’s MMS Story  ](https://mmsholdings.com/perspectives/academia-to-medical-writing/): After working in academic research, Jessica Murdock, PhD, transitioned into a technical role in medical writing and is now a principal medical writer at MMS. Her excellent leadership and strong communication skills drive collaboration and progress at MMS. 
- [Ready by Design: Endpoints, Feasibility, and Scenario Testing](https://mmsholdings.com/perspectives/cmo-trial-design/): Hitting a primary endpoint on paper is only half the story. When trying to get positive attention from investors, research teams inspire confidence when the plan holds up in the real world. Investors evaluate early clinical plans for confidence, clarity, and clinical realism. Timelines need to reflect how sites operate, how patients live, and how enrollment ebbs and flows. This is where feasibility and scenario modeling, along with strong biostatistical insights, turn a good design into an executable one, and one that investors want to buy into. Chief Medical Officers (CMOs) can set the tone by pairing clinical priorities with the modeling work that proves the plan can be successful. 
- [The Chief Medical Officer–Statistician Partnership: How Alignment Builds Investor Confidence](https://mmsholdings.com/perspectives/cmo-statistician-investor-confidence/): The Chief Medical Officer (CMO) statistician alignment is critical in investor meetings. These conversations move quickly. The questions are pointed, the clock is ticking, and people in the room want to feel confident that the clinical vision is supported by the data. Put simply, investors are looking for visible alignment between clinical leadership and biostatistics, and they expect to see a plan that has been pressure-tested with data and scenarios. 
- [Design To De-Risk, The Fastest Way To Earn Investor Trust](https://mmsholdings.com/perspectives/clinical-trial-design-derisk/): Early clinical development is where confidence is won or lost. Investors fund plans that hold up under pressure, so they look for signs that a team has translated strong biology into an executable, decision-ready study. The fastest way to show that readiness is through design choices backed by biostatistics and scenario modeling. When a Chief Medical Officer (CMO) is fully briefed on the logic for endpoints, assumptions, timelines, and risk controls, investor conversations become clearer and more productive. 
- [Advancement of Personalized Treatment Strategies in Oncology Companion Diagnostics and Biomarkers ](https://mmsholdings.com/perspectives/oncology-companion-diagnostics/): The future of cancer treatment is “personal”. With precision medicine, we’re entering an era where treatments are smarter, more effective, and designed just for you. In this blog, we’ll explore how companion diagnostics are transforming the future of oncology.  
- [The State of AI Adoption in Medical Writing](https://mmsholdings.com/perspectives/ai-adoption-medical-writing/): Artificial intelligence (AI) is already poised for transformational impact across diverse applications within life sciences, and the field of medical writing is no exception. But where do organizations actually stand today in their adoption curve, and what are the greatest opportunities that lie ahead? 
- [Career Insights: Shervin Maleki on Data Science and Healthcare Innovation](https://mmsholdings.com/perspectives/career-insights-data-science/): In our most recent edition of the Career Insights blog series, we had the pleasure of speaking with Shervin Maleki, a Senior Data Scientist at MMS. He shares his curiosity in data science, his professional journey, and walks us through his everyday work. He also provides insight into the unique opportunities of his role.
- [Optimizing Data Management for Oncology Clinical Trials: Design and Technology Best Practices](https://mmsholdings.com/perspectives/oncology-data-management/): In oncology trials, data complexity is a given. Heterogeneous sources, high safety reporting, imaging, biomarker integration, and real-time oversight are the norm. That complexity requires a clinical data management (CDM) strategy that is tightly aligned with study objectives, efficient in execution, and adaptive to changing trial conditions.
- [Before You Launch Your Next Oncology Trial, Run the Simulation ](https://mmsholdings.com/perspectives/oncology-clinical-trial-design-simulation-solutions/): Oncology doesn’t leave much room for clinical trial design missteps. When survival can be measured in weeks or months, and endpoints are increasingly complex, the ability to plan thoroughly is critical. This context makes simulation a powerful tool for clinical trial planning. 
- [Why Quality by Design Is Still Underused in Emerging Biotech, and What Can Be Done About It](https://mmsholdings.com/perspectives/why-biotechs-should-adopt-quality-by-design-early/): Quality by Design (QbD) is widely recognized as a best practice for improving clinical trial quality, ensuring regulatory readiness, and avoiding costly delays So why do so many early-stage biopharma and biotech companies still treat it as optional? 
- [Career Insights: From Military Service to Regulatory Strategy – Ritchie Patton’s Journey at MMS](https://mmsholdings.com/perspectives/career-insights-ritchie-patton-regulatory-strategy/): In this first edition of our new Career Insights blog series, it was incredible to speak with Ritchie Patton, Associate Director of Regulatory Strategy at MMS. In our interview, Ritchie walks us through his professional journey, applying lessons from his military service to regulatory strategy in clinical trials.
- [Smart AI, Smarter Oversight: What Sponsors Really Need from Their CRO ](https://mmsholdings.com/perspectives/ai-in-clinical-trials-cro-oversight-data-science-automation/): In clinical trials today, artificial intelligence (AI) is everywhere and nowhere all at once. Conferences are packed with AI panels. Vendors promise intelligent automation. Sponsors ask how AI will speed them to database lock or regulatory submission. But when it comes to real, practical implementation, many teams are still figuring out what AI can do, what it should do, and what actually counts as AI at all. 
- [Guidance for Working with External Data Vendors – Getting from LPLV to Database Lock Faster](https://mmsholdings.com/perspectives/external-data-vendor-management-for-faster-database-lock/): There are a lot of roadblocks on the way to a successful database lock. Getting there efficiently means managing a massive amount of incoming data, aligning timelines across multiple stakeholders, and responding quickly to issues before they become delays. When external data vendors are involved, that challenge multiplies. 
- [Why Real-Time Data Access Matters (and How to Make the Most of It)](https://mmsholdings.com/perspectives/real-time-data-access-clinical-trials-oversight/): Real-time visibility into operational and quality metrics isn't just a convenience anymore — it's becoming essential. Across the industry, sponsors and service providers alike are realizing that the traditional model of static, delayed reporting no longer meets the demands of modern clinical trials. 
- [Why Now Is the Time for Specialized, Data-Focused CRO Partners](https://mmsholdings.com/perspectives/specialized-data-focused-cro-clinical-trials/): To succeed in this environment, sponsors need more than a service provider. They need a specialist. And when it comes to clinical trial data, that means a partner that brings deep expertise, flexibility, and a proactive mindset across the entire biometrics lifecycle. 
- [Solving Data Complexity with Real-Time Insights, Predictive AI, and Smarter Decision-Making with Datacise](https://mmsholdings.com/perspectives/clinical-data-platform-datacise-ai-insights/): Fresh off a major award win for Datacise®, the Perspectives team sat down with Kris Wenzel, MBA, Senior Manager of Data Science at MMS, to talk about how this powerful clinical data platform is changing the way that Sponsors manage and act on their clinical trial data.
- [Applying Artificial Intelligence (AI) and Real-World Evidence to Boost Efficiency in Patient Safety Narratives ](https://mmsholdings.com/perspectives/ai-rwe-patient-safety-narratives/): In line with other sectors, the life science industry has been increasingly exploring and adopting applications of automation and artificial intelligence (AI) to boost efficiency across the development life cycle. One area in particular is the authoring of Patient Safety Narratives, critical documents authored by Medical Writers describing the clinical course of a patient’s adverse event. This is compelling as an AI and automation use case due to the high volumes of written narratives required to support regulatory submissions. 
- [Choosing the Right Strategy: Parallel, Sequential, and Staggered Regulatory Submissions ](https://mmsholdings.com/perspectives/global-submission-strategy-parallel-sequential-staggered/): In today’s global pharmaceutical landscape, bringing a product to market often means filing marketing applications in multiple regions. Regulatory teams face strategic decisions about submissions, like choosing to file in all target markets simultaneously (parallel submissions), taking a step-by-step approach (sequential), or balancing somewhere in between (staggered). Each pathway has its own strategic and operational implications.  

## Webinars
- [The Shift Toward Parallel Submissions in Global Regulatory Strategy](https://mmsholdings.com/webinars/parallel-global-regulatory-submissions/): Learn how leading regulatory experts are helping sponsors accelerate global submissions through parallel filing strategies, early agency alignment, and practical execution across multiple regulatory pathways.
- [How AI Is Being Applied to Accelerate Submission Readiness and Reduce Time to Filing ](https://mmsholdings.com/webinars/ai-faster-regulatory-submissions/): Artificial Intelligence (AI) is rapidly moving from experimentation to practical application in regulatory operations, but adoption must be handled with care. This fireside chat webinar explores how AI is being applied today to support submission readiness, improve content consistency, and reduce timelines, without compromising quality, compliance, or regulatory confidence. 
- [Making the Right Decisions With Incomplete Evidence in Early-Phase Oncology Trials](https://mmsholdings.com/webinars/early-phase-oncology-trials-decision-making/): Early-phase oncology trials operate under significant uncertainty. Teams are often required to make critical decisions—such as dose escalation, cohort expansion, or program progression—while data is still emerging and incomplete.
- [Inside FDA REMS Decision-Making: A Fireside Chat for Sponsors](https://mmsholdings.com/webinars/fda-rems-decision-making/): Risk Evaluation and Mitigation Strategies (REMS) play a critical role in ensuring that the benefits of certain therapies outweigh their risks, but they are often misunderstood, inconsistently interpreted, and challenging to operationalize.
- [Technology Use Cases: Shaping the Future of Trial Design and Implementation](https://mmsholdings.com/webinars/clinical-trial-technology/): Clinical development is undergoing rapid transformation as trial designs grow more complex, data sources multiply, and operational uncertainty increases. Sponsors face rising pressure to design smarter trials, reduce failure rates, and make decisions earlier with greater confidence. Yet many of today’s challenges such as flawed protocol assumptions, delayed insights, unnecessary rework remain preventable with correct clinical trial technology combined with human expertise.
- [Writing with Quality Control in Mind: A Cross-functional Approach ](https://mmsholdings.com/webinars/qc-writing-strategies/): Biotech and pharma teams face mounting pressure to deliver high-quality documents that meet regulatory standards, accelerate timelines, and minimize costly rework. Yet, many organizations still treat Quality Control (QC) as a final checkpoint, missing opportunities to embed quality throughout the writing process. This can lead to inefficiencies, repeated reviews, and increased risk of errors.
- [De-Risking Development with Specialized Data Strategies: From Trial Design to Submission](https://mmsholdings.com/webinars/de-risking-development-with-specialized-data-strategies/): In this on-demand webinar, MMS data and regulatory experts, along with industry leaders, discuss how biotech organizations can de-risk development by embedding specialized data strategies from the earliest stages — from trial design through submission. The panel explores how proactive, data-driven decision-making enables sponsors to anticipate regulatory needs, identify risks earlier, and accelerate timelines.
- [A Practical Guide to Expedited Regulatory Pathways](https://mmsholdings.com/webinars/expedited-regulatory-pathways/): Accelerating development timelines requires more than ambition—it demands strategy. In this on-demand webinar, MMS experts share actionable insights into how sponsors can effectively navigate expedited regulatory pathways to bring therapies to patients faster, particularly in areas of high unmet medical need.
- [The Psychedelic Inflection Point: What Sponsors Need to Know Now](https://mmsholdings.com/webinars/psychedelic-drug-development/): The psychedelic field is entering a new era. From early regulatory engagement to pending regulatory acceptance, what once felt fringe is now center stage with unprecedented attention from regulators and policymakers fueling a surge in medical and commercial possibility. At the heart of this momentum lies serious unmet need in treatments for numerous complex psychiatric, neurological and immune conditions and the promising results of psychedelics studied in difficult to treat disorders such substance use disorders, depression, and anxiety and trauma-related disorders.  Regulation of psychedelics as a treatment option with reimbursement represents a significant opportunity for patients, sponsors, and overall public health. However, as with all medicines, opportunities come with risk and an array of regulatory and clinical complexities for developers trying to deliver therapies with a positive Benefit-Risk Assessment.
- [Shaping the Future of AI-Enabled Medical Writing](https://mmsholdings.com/webinars/ai-medical-writing-webinar/): With artificial intelligence and automation use cases rapidly reshaping clinical development, the medical writing function is undergoing significant transformation. From automating plain language summaries to supporting regulatory authoring workflows, AI and automation offer the potential to enhance consistency, accelerate timelines, and ease resource constraints. But what does the rise of these emerging technologies mean for the future of medical writing, and how are roles evolving in response? 
- [Design, Data, and Decisions in Oncology Trials](https://mmsholdings.com/webinars/oncology-trial-design-data-decision-making-webinar/): From complex trial designs and cycle time pressures to the ongoing challenge of integrating diverse data sources, oncology studies continue to push the boundaries of scientific innovation and data-driven decision-making. 
- [Advancing Clinical Development with Innovative Trial Design and Regulatory Strategies](https://mmsholdings.com/webinars/innovative-trial-design-webinar/): Biotech organizations face a series of high-stakes decisions when designing their clinical development programs. These decisions involve balancing speed, cost, regulatory risk, and trial delivery. Too often, companies default to traditional study designs and endpoints—missing opportunities to reduce patient numbers, streamline approval pathways, and enhance overall efficiency. This hesitation may be driven by a lack of awareness of available options, concerns about regulatory acceptance, or implementation challenges. However, by leveraging close collaboration between biopharma scientific leaders, statistical design experts, and regulatory strategists, companies can identify optimal trial designs that enhance success rates, reduce risk and cost, increase label coverage, and accelerate timelines. In some cases, these efficiencies can translate into savings of years of development time and tens of millions of dollars.
- [Overcoming NDA/BLA Submission Challenges: Practical Strategies for Success](https://mmsholdings.com/webinars/nda-bla-submission-challenges-webinar/): Submitting a New Drug Application (NDA) or Biologics License Application (BLA) is one of the most critical and complex milestones in drug development, marking the culmination of years of cross-disciplinary effort.
- [Optimal Strategies to Protect Commercially Confidential Information (CCI) in Clinical Documents and Report Trial Results Under Revised EU-CTIS Transparency Rules](https://mmsholdings.com/webinars/cci-protection-eu-ctis-webinar/): In this Expert Insights webinar, MMS will present real-time experience working on EU-CTIS submissions under non-deferral strategies, collating concerns from Sponsor teams, project planning, timelines required, and trends observed in additional redaction criteria for CCI of several in-scope documents. Additionally, MMS transparency experts will share practical scenarios to approach the redaction of documents in CTA, clinical study reports, and reporting of summary results for ‘trial results’ sections for clinical trials.
- [Regulatory Pathways for Nonprescription Drugs: A Deep Dive into OTC Monograph Reform and FDA Guidance](https://mmsholdings.com/webinars/otc-monograph-reform-fda-guidance/): There are two regulatory pathways to bring a nonprescription drug to market in the United States: the drug application process and the Over-the-Counter (OTC) Drug Monograph process. This webinar, featuring MMS's Ritchie Patton, MBA, with insights from Dr. Jay Sirois, Vice President of Regulatory and Scientific Affairs at the Consumer Healthcare Products Association, will review principles of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, signed into law in 2020, which reformed and modernized the framework for the regulation of OTC monograph drugs.
- [No Stone Unturned: Optimizing the Use of Expedited Pathways and Oncology Center of Excellence Programs to Optimize Drug Development in Oncology](https://mmsholdings.com/webinars/no-stone-unturned-optimizing-the-use-of-expedited-pathways-and-oncology-center-of-excellence-programs-to-optimize-drug-development-in-oncology/): It is a fundamental human instinct to do everything possible for the cancer patients in our lives. We leave no stone unturned in providing comfort and seeking out the best care. As drug development professionals, we have a unique opportunity to extend this approach beyond the personal level and into our work.
- [The Rising Burden of Pharmacovigilance (PV) Requirements in Early Drug Development](https://mmsholdings.com/webinars/rising-pharmacovigilance-burden-early-drug-development/): As clinical trials become more complex and sites are spread further across multiple countries and regions, the pharmacovigilance regulatory compliance burden has significantly increased for Sponsors. Specifically designed for early-stage drug development Sponsors, MMS experts explore and share what constitutes a compliant pharmacovigilance program and discuss considerations as the new therapy progresses through key milestones. Understanding of these requirements will help Sponsors properly plan and make informed decisions.
- [A Psychedelic Shift: Assessing the Potential for Nonmedical Use in a Changing Regulatory Landscape](https://mmsholdings.com/webinars/nonmedical-use-psychedelics-fda-guidelines/): The US Food & Drug Administration (FDA) requires that the potential for nonmedical use must be assessed for any investigational new drug that has CNS activity. Current regulatory recommendations may lack the nuance required to appropriately evaluate drugs with novel or previously unrecognized drivers of nonmedical use. Capturing and assessing the experiences, subjective effects, and/or changes in consciousness that may drive additional use for psychedelic drugs poses a challenge for the industry as a whole.
- [Type II Drug Master Files for Early-Stage, Small Molecule, Drug Development: Regulatory Management, Quality Considerations, and eCTD Submission](https://mmsholdings.com/webinars/mastering-type-ll-drug-master-files-guide/): Despite the 2019 publication of the FDA Guidance, Drug Master Files, considerable questions remain regarding the regulatory management, quality considerations, and electronic submission of Drug Master Files (DMF). Dive deep into the world of Type II Drug Master Files (DMFs) with our comprehensive webinar, designed specifically for early-stage sponsors engaged in small molecule drug development.
- [Best Practices for Data Visualization in Pharma, presented by MMS Holdings Data Science leaders](https://mmsholdings.com/webinars/pharma-data-visualization-best-practices-mms/): This Expert Insights webinar will focus on best practices for data visualization in the pharmaceutical industry. Data practitioners and consumers are increasingly dissatisfied with static and out-of-date views of their data. There is an increasing need in the pharmaceutical industry for interactive visualization tools and analytical strategies to gain better data insights using near-real-time data. This is particularly true in the current era where advanced technologies are producing Real World Data (RWD) at an astronomical pace and these data are becoming more commonly used. The ability to quickly gain insights from data used to be an advantage, but now it is a requirement.
- [The Wisdom Study: Revolutionizing Breast Cancer Screening, Detection & Prevention](https://mmsholdings.com/webinars/wisdom-study-breast-cancer-screening/): This webinar highlights the pioneering WISDOM Study, with our CEO, Dr. Uma Sharma, leading the conversation, followed by insights from Dr. Laura Esserman, Founder of the WISDOM Study and Director of the UCSF Breast Care Center. This session promises to shed light on innovative approaches in breast cancer screening and prevention. Embarking on its remarkable 8th year with the involvement of over 60,000 women across the nation, the WISDOM Study (Women Informed to Screen Depending on Measures of risk) continues to lead transformative changes in breast cancer screening protocols. The initiative champions personalized screening, challenging conventional methods, especially with the launch of WISDOM 2.0. This progression includes comprehensive genetic testing and counseling, now accessible to women starting from age 30. This webinar will delve into how these advancements are setting new standards in the realm of precision medicine, contributing to more accurate, timely, and preventative healthcare solutions.
- [Evolving Your FSP Relationships to Achieve Maximum Return](https://mmsholdings.com/webinars/maximizing-fsp-relationships-drug-development/): The drug development lifecycle can be predictably unpredictable, as mergers and acquisitions, interim results, DSMB decisions, reorganization, and evolving technology can all change the course of any plan in short order. Sponsors rely on the ability of Clinical Research Organization (CRO) partners to provide scalability and global reach in support of their core teams. FSP relationships, however, can go beyond the ability to quickly ramp up and down. Explore with us, as we discuss how Sponsors who leverage FSP partners across multiple interdependent functional lines achieve the maximum benefit and the increasing importance of the way that new innovations and technology continue to change the way we work and the future skillsets needed.
- [Avoiding Common Pitfalls in the IND & CTA Submission Process](https://mmsholdings.com/webinars/ind-cta-submission-best-practices/): When planning an Investigational New Drug (IND) or Clinical Trial Authorization (CTA) submission, navigating FDA, EMA, and other regulations can be challenging and creating scientifically-sound strategies are essential. As submissions expand to multiple countries during later phase trials, greater challenges can arise if not prepared with knowledge of the requirements, proper time management, and defined roles for the team towards approval. Join us as experts in project management, medical writing, and regulatory operations discuss best practices for a successful submission process from start to finish.
- [How to Use Machine Learning in Clinical Research Right Now](https://mmsholdings.com/webinars/machine-learning-clinical-research/): In machine learning, there are usually one of two distinct objectives: inference or prediction. In analyses involving clinical trial data and/or real-world data, a machine learning solution can be used by data scientists to detect patterns that conventional analysis and statistical methods cannot. Thus, a machine learning practitioner can help to infer which subgroups that respond, either particularly well or poorly, to a treatment. Similarly, machine learning algorithms can be used to predict a discrete or time-to-event outcome. When knowledge increases of subgroups of interest and on outcomes before they occur, the impact on patient care and clinical research is very powerful.
- [EU Clinical Trials Regulation: The Clinical Trial Transparency Revolution](https://mmsholdings.com/webinars/eu-clinical-trials-regulation-transparency-revolution/): The EU Clinical Trials Regulation (Regulation No 536/2014) will enter in force in January 2022, changing clinical trial processes in Europe and impacting clinical trial activities worldwide. At the center of this new CT Regulation is the EU Clinical Trials Portal, a single-entry point for Sponsors, Health Authorities, and the public. For the first time, European citizens and the rest of the world will have access to almost all study documents and data. This webinar will explore how the new CT Regulation will impact sponsors, and will take a closer look at changes to clinical trials processes, protocols, Informed Consent for minors, and impact to lay summaries. To prepare for this major step, Sponsors will have to rethink their clinical trial disclosure and transparency policies and supporting processes.
- [Blueprint for Success for Effective and Efficient Clinical Protocols](https://mmsholdings.com/webinars/effective-clinical-protocols-blueprint/): Clinical study protocols are vital to drug development, and when carefully designed, deliver practical clinical care and answer critical research questions. This balance of science and medicine provides the foundation for advancing the next big idea from the laboratory to the pharmacy. Still, this achievement is dependent on each drug’s ability to demonstrate safety and effectiveness during the phases of a clinical trial. Explore with us as we discuss different protocol writing and study design approaches, ensuring protocols are designed to meet both the patients’ and Sponsor’s needs, and maintaining compliance with the International Council for Harmonisation requirements.
- [Rare Disease Research in the US, Part 2](https://mmsholdings.com/webinars/rare-disease-research-us-part-2/): The Orphan Drug Act (ODA) defines a rare disease as a disease or condition that affects less than 200,000 people in the United States.  Within this range we see conditions like sickle cell disease with a prevalence of over 100,000, down to rare genetic diseases that may occur in a handful of patients. As approaches to clinical development are constrained by issues of enrollment and statistical powering, the categories defined by prevalence distribution (rare, ultra-rare and uber-rare) require differing approaches within the framework of identical statutory standards for safety and efficacy. At the level of the ultra and uber-rare conditions that make up the majority of rare disease, there is an unmet need not only for treatments but also for the tools to evaluate whether a given treatment works.
- [Rare Disease Research in the US, Part 1](https://mmsholdings.com/webinars/rare-disease-research-us-part-1/): The Orphan Drug Act (ODA) defines a rare disease as a disease or condition that affects less than 200,000 people in the United States.  Within this range we see conditions like sickle cell disease with a prevalence of over 100,000, down to rare genetic diseases that may occur in a handful of patients. As approaches to clinical development are constrained by issues of enrollment and statistical powering, the categories defined by prevalence distribution (rare, ultra-rare and uber-rare) require differing approaches within the framework of identical statutory standards for safety and efficacy. At the level of the ultra and uber-rare conditions that make up the majority of rare disease, there is an unmet need not only for treatments but also for the tools to evaluate whether a given treatment works.
- [Orphan Drug, Rare Pediatric Disease and Expedited Program Designations](https://mmsholdings.com/webinars/rare-disease-expedited-programs-fda/): Substantial progress continues in the development of treatments for rare diseases or orphan products. In 2020, 32 novel drugs and biologics were FDA approved with orphan drug designation status. Notably, 1 of 5 (20%) novel biologic approvals in the Center for Biologics Evaluation and Research (CBER)—although not orphan designated—was used in rare diseases. In the Center for Drug Evaluation and Research (CDER), 31 of 53 (58%) novel drug approvals were orphan designated products. Unfortunately, 1 in 10 (25 to 30 million) Americans is affected by rare diseases (more than half of which are children), and approximately 95% of the more than 7,000 rare diseases have no treatments available.
- [Strategies for Rare Disease Data Analysis – Doing More with Less](https://mmsholdings.com/webinars/strategies-rare-disease-data-analysis/): The pharmaceutical industry’s burgeoning desire to develop rare disease treatments to address significant unmet needs presents many challenges with identifying and utilizing fit-for-purpose data. In addition, patient identification and retention are major hurdles for rare disease development programs. Real-world data (RWD) such as electronic health records (EHR), claims, and genomics can be paired with data visualization and analysis techniques to discover subjects with diagnostic criteria suggestive of a rare disease disorder. Further, descriptive dashboards are useful in determining the viability and value that may come from particular data points collected in a clinical development program. Dashboards can help answer whether the data is fit-for-use, has sufficient quality, and is informative for decision making. Using dashboards from a purpose-built platform like Datacise™ can assist clinicians and other researchers in making key decisions for the planning and evaluation of research trials. Datacise™ has been developed by MMS, a data-focused CRO, as a solution for RWD curations, analytics, and data visualization.
- [Tips for Efficient and Effective New Drug Application (NDA) Submissions](https://mmsholdings.com/webinars/efficient-effective-nda-submissions-tips/): his Expert Insights webinar will demonstrate New Drug Applications (NDAs) are the final step of a long clinical development process and the most important deliverable a pharmaceutical company produces. Submitting a complete, comprehensive, and acceptable package is complex and time-consuming. After supporting more than 10 NDA submissions in five years, MMS statistical programmers know how to do this efficiently and effectively. Listen and learn as our panel of global experts discuss best practices and share tips to help your next NDA submission go smoothly.
- [Insights and Trends from 2021 FDA GCP Inspections](https://mmsholdings.com/webinars/fda-gcp-inspections-2021-insights-trends/): The FDA oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and good clinical practice (GCP) regulations. Reviewing inspection observations and trends from 2021 can help clinical researchers determine common issues, highlight potential quality management gaps and identify improvement opportunities.
- [Strategies for Navigating ICH E9(R1): Considerations for Using Estimands and Sensitivity Analysis in Clinical Trials](https://mmsholdings.com/webinars/ich-e9r1-estimands-sensitivity-analysis-strategies/): The ICH E9(R1) Addendum on ‘Estimands and Sensitivity Analysis in Clinical Trials’ introduced a framework to align planning, design, conduct, analysis, and interpretation of clinical trials.  
- [How to Create Fit-For-Purpose Clinical Study Reports for Successful Submissions](https://mmsholdings.com/webinars/fit-for-purpose-clinical-study-reports/): A clinical study report (CSR) is an essential building block of a clinical submission. The ICH and FDA provide guidance for the structure and content of CSRs and instances when an abbreviated or synoptic CSR format should be used in place of a full CSR format, depending on the role of the CSR in a submission. Thoughtful selection of the CSR format based on study attributes, along with tailoring the template to include the appropriate data will help create a regulatory-compliant CSR and a successful downstream submission.
- [Data Management Considerations for Decentralized Clinical Trial Implementation](https://mmsholdings.com/webinars/decentralized-clinical-trial-data-management/): Recent improvements in clinical trial technology hardware, software, and applications have led to them being more user-friendly. These improvements have changed the implementation of clinical trials, allowing remote participation because of the increased accessibility and use of technology. Through electronic consent, electronic diaries, electronic clinical outcome assessments, wearables (e.g., a GPS or heart rate monitor), and telehealth, Decentralized Clinical Trials (DCTs) allow better access to clinical trials than ever before. In this webinar, MMS data managers will review the basics of decentralized clinical trials and expand on how to address challenges that may arise when working on a DCT.
- [How to Submit Non-Clinical Data to CBER Using SEND : Understanding New FDA Requirements](https://mmsholdings.com/webinars/submit-non-clinical-data-cber-fda-send-requirements/): The FDA’s CBER will begin requiring electronic submissions of nonclinical data to be submitted using the 3.1 and 3.1.1 versions of CDISC SENDIG on March 15th, 2023. With these requirements taking effect soon, Sponsors need to understand how to meet the new rules and regulations provided by SEND, as failing to meet them could result in FDA refusal.
- [Using Natural Language Processing to Curate Unstructured Electronic Health Records into Research Ready Datasets](https://mmsholdings.com/webinars/nlp-curating-unstructured-health-records-icoda-case-study/): This presentation provides an overview of Natural Language Processing (NLP), an Artificial Intelligence technique that can be used to curate unstructured medical records. We will see NLP in action as part of the ICODA Grand Challenges ‘PRIEST’ project (Pandemic Respiratory Infection Emergency System Triage) Study for Low and Middle-Income Countries as a case study.
- [EU CTR Compliance and Success: Navigating Updates and Preparing Submissions for the EU CTIS Portal](https://mmsholdings.com/webinars/eu-clinical-trials-submissions-best-practices/): As of January 31, 2023, Sponsors are required to submit all new trial applications for authorization in the European Union through the Clinical Trial Information System (CTIS) in compliance with the new European Union Clinical Trials Regulation (EU CTR). With the new regulation, Sponsors are seeking guidance with questions such as: what types of documents to include, processes, timelines, and how to protect confidential information, among others. Not fully understanding the process could result in releasing unprotected data or withdrawing the application due to unmet deadlines and requirements.

## Regulatory Intel
- [Navigating the National Priority Review Voucher: Challenges and Solutions ](https://mmsholdings.com/regulatory/fda-national-priority-review-voucher-nprv-challenges-solutions/): In June 2025, the FDA introduced the National Priority Review Voucher (NPRV) program, an initiative designed to fast-track reviews for drugs deemed critical to U.S. national interests. Promising a one to two-month review window from final submission, this scheme significantly compresses the expected PDUFA timelines, which typically span six to ten months.  
- [Key MedDRA Coding Gaps Highlighted at the ISCTM 2025 Scientific Meeting](https://mmsholdings.com/regulatory/meddra-coding-gaps-psychedelic-trials-isctm-2025/): At the 21st Annual Scientific Meeting of the International Society for CNS Clinical Trials and Methodology (ISCTM) in Washington, DC, earlier this year, MMS Senior Director of Regulatory Strategy Dr. Amanda Beaster presented a poster addressing a growing issue in psychedelic drug development: the underreporting of psychoactive effects due to gaps in MedDRA coding practices. 
- [The FDA’s AI Guidance and its Seven Steps into the Future of Drug Development](https://mmsholdings.com/regulatory/the-fdas-ai-guidance-and-its-seven-steps-into-the-future-of-drug-development/): On January 6, 2025, the US FDA released a highly anticipated guidance on the use of artificial intelligence (AI) in drug development. The guidance is centered on potential use of AI models to support regulatory decision making regarding the safety, effectiveness, or quality of drugs. Because such models potentially encompass all disciplines within drug development, this FDA guidance should be of broad interest, and sponsor input across functions will be critical in ensuring the future applicability of the proposed AI approach. 
- [New FDA Protocol Deviation Guidance:  Planning for the Things That Don’t Go According to Plan](https://mmsholdings.com/regulatory/new-fda-protocol-deviation-guidance-planning-for-the-things-that-dont-go-according-to-plan/): A systematic, proactive, and carefully considered approach to protocol deviations is a powerful tool in drug development with direct impacts on the interpretability of clinical trial results. The direction provided by strong SOPs and work practices for protocol deviations facilitates decision making, accuracy of Clinical Study Reports, and optimal positioning of Marketing Applications.    
- [FDA Issues Detailed Guidance on Development of Gene Therapy Products](https://mmsholdings.com/regulatory/fda-issues-detailed-guidance-on-development-of-gene-therapy-products/): Earlier in November, the FDA Center for Biologics and Research (CBER) released a new FAQ for developers of cellular and gene therapy (CGT) products. Sponsors of CGT products planning INTERACT, Type-D, Pre-IND or pre-BLA meetings with the Agency will benefit from starting their question development with a detailed review of this guidance. 
- [Recent Guidance on Diversity Action Planning](https://mmsholdings.com/regulatory/diversity-action-planning/): As the science behind regulatory approvals advances to incorporate smaller patient populations, novel study designs, surrogate endpoints, and real-world evidence, an important unmet need has become increasingly apparent: the need for drug approvals supported by generalizable data obtained through recruiting more diverse patient populations. 
- [Oncology Programs at the FDA](https://mmsholdings.com/regulatory/oncology-programs-at-the-fda/): Time spent developing novel cancer therapies is frequently measured in decisions as much as duration--each decision may speed a promising therapy to patients or lead to delay. For sponsors, understanding the full scope of programs offered by the FDA to speed up the approval of cancer treatments is critical.  
- [Three Key Reflections on the Recent Donanemab Approval](https://mmsholdings.com/regulatory/three-key-take-reflections-on-the-recent-donanemab-approval/): The last 20 years of drug development in Alzheimer’s disease reflect a coevolution of imaging agents and amyloid-targeting monoclonal therapies, informed by the amyloid hypothesis and predicated on the need for early intervention which, itself relies on early visualization of PET biomarkers.  This co-evolution is reflected in approval trends within the Alzheimer’s space: from accelerated approval based on the surrogate endpoint of amyloid plaque reduction (aducanumab), to surrogate endpoint-based accelerated approval followed by full approval using clinical endpoints (lecanemab) to, in the case of the July 2, 2024 donanemab decision, full approval based on clinical endpoints following an earlier rejection of accelerated approval.
- [FDA Updates 2024 Language Access Plan](https://mmsholdings.com/regulatory/fda-updates-2024-language-access-plan/): "On Thursday, the FDA released its updated 2024 Language Access Plan, taking another key step toward addressing language barriers that impact health equity and strengthening language access to health information and services for the public, including people with Limited English Proficiency and people with disabilities. The plan also supports FDA efforts to identify interpretation language assistance, translate, and make important documents accessible, as well as digital and web content into multiple languages. The Language Access Program, led by the FDA’s Office of Minority Health and Health Equity, is a part of the FDA’s ongoing work to help individuals make informed decisions about their health."
- [EMA Launches New Pilot Program for Orphan Medical Devices](https://mmsholdings.com/regulatory/ema-launches-new-pilot-program-for-orphan-medical-devices/): From the EMA: "EMA has launched a pilot programme for expert panels to support the development and assessment of orphan medical devices in the European Union (EU). The pilot programme offers free advice from the medical device expert panels to selected manufacturers and notified bodies on the orphan device status and the data needed for their clinical evaluation. While the pilot programme is currently scheduled to run until the end of 2025, the aim is to establish a long-term process for orphan device support."
- [Key Decision Points for Recent Oncology Approvals](https://mmsholdings.com/regulatory/key-decision-points-for-recent-oncology-approvals/): In keeping with our theme of forking paths, I would like to highlight three critical decision points illustrated by these approvals:  the decision to participate in Project Orbis, the submission of Assessment Aids, and the use of the Real Time Oncology Review process.   
- [Comments Open for Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products](https://mmsholdings.com/regulatory/comments-open-for-postapproval-manufacturing-changes-to-biosimilar-and-interchangeable-biosimilar-products/): From the FDA: "This guidance provides answers to commonly asked questions from applicants and other interested parties (collectively referred to as applicants throughout this guidance) regarding postapproval manufacturing changes (referred to as manufacturing changes throughout this guidance) made to licensed biosimilars and licensed interchangeable biosimilars. This question-and-answer (Q&A) guidance is intended to inform prospective and current applicants of the nature and type of information that applicants should provide in support of manufacturing changes to licensed biosimilars and licensed interchangeable biosimilars in different reporting categories."
- [FDA Works to Reduce the Spread of Misinformation](https://mmsholdings.com/regulatory/fda-works-to-reduce-the-spread-of-misinformation/): The U.S. Food and Drug Administration (FDA) recently issues a press release to help address and reduce the spread of misinformation. The FDA has taken steps to update its draft guidance titled, "Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers."
- [New Details on Diversity Action Plans Provided by the US FDA](https://mmsholdings.com/regulatory/new-details-on-diversity-action-plans-provided-by-the-us-fda/): On June 26, 2024, the US FDA released a draft guidance titled, Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.

## Events
- [4th Annual COG Europe 2026](https://mmsholdings.com/events/cog-europe-2026/)
- [Bay Area Biotech Week (BBSW) 2026](https://mmsholdings.com/events/bay-area-biotech-week-bbsw-2026/)
- [AMWA Medical Writing & Communication Conference 2026](https://mmsholdings.com/events/amwa-medical-writing-conference-2026/)
- [OCT DACH 2026](https://mmsholdings.com/events/oct-dach-2026/)
- [CNS Summit 2026](https://mmsholdings.com/events/cns-summit-2026/)
- [OCT New England 2026](https://mmsholdings.com/events/oct-new-england-2026/)
- [OCT Nordics 2026](https://mmsholdings.com/events/oct-nordics-2026/)
- [CTSS San Francisco 2026](https://mmsholdings.com/events/ctss-san-francisco-2026/)
- [CTSS London 2026](https://mmsholdings.com/events/ctss-london-2026/)
- [RAPS Convergence 2026](https://mmsholdings.com/events/raps-convergence-2026/)
- [Nordic Life Science Days 2026](https://mmsholdings.com/events/nordic-life-science-days-2026/)
- [TOPRA Annual Symposium 2026](https://mmsholdings.com/events/topra-annual-symposium-2026/)
- [SCDM Annual Conference 2026](https://mmsholdings.com/events/scdm-annual-conference-2026/)
- [BIO International Convention 2026](https://mmsholdings.com/events/bio-international-convention-2026/)
- [Boston RAPS Biogen Executive Chat 2026](https://mmsholdings.com/events/boston-raps-biogen-executive-chat-2026/)
- [PSI 2026 Conference](https://mmsholdings.com/events/psi-conference-2026/)
- [World Orphan Drug Congress](https://mmsholdings.com/events/world-orphan-drug-congress-2026/)
- [OCT East Coast](https://mmsholdings.com/events/oct-east-coast-2026/)
- [MichBio Drug Discovery & Development Symposium](https://mmsholdings.com/events/michbio-drug-discovery-symposium-2026/)
- [OCT Europe](https://mmsholdings.com/events/oct-europe-2026/)
- [21st Clinical Trials Strategic Summit](https://mmsholdings.com/events/clinical-trials-strategic-summit-2026/)
- [6th Annual Psychedelic Therapeutics and Drug Development Conference](https://mmsholdings.com/events/psychedelic-therapeutics-conference-2026/)
- [CMO Summit 360](https://mmsholdings.com/events/cmo-summit/)
- [RIC Annual Meeting](https://mmsholdings.com/events/ric-annual-meeting/)
- [Phuse Main Conference – US Connect](https://mmsholdings.com/events/phuse-us-connect/)
- [ACDM EU 26](https://mmsholdings.com/events/acdm/)
- [4th Annual COG UK](https://mmsholdings.com/events/cog-uk/)
- [OCT West Coast](https://mmsholdings.com/events/oct-west-coast/)
- [ JP Morgan Healthcare Conference](https://mmsholdings.com/events/jp-morgan-healthcare-conference/)
- [Regulatory Affairs Professionals Society (RAPS)](https://mmsholdings.com/events/regulatory-affairs-professionals-society-raps/)
- [CNS Summit](https://mmsholdings.com/events/cns-summit/)
- [Clinical Trials in Rare Diseases EU](https://mmsholdings.com/events/clinical-trials-in-rare-diseases-eu/)
- [Phuse Main Conference – EU Connect](https://mmsholdings.com/events/phuse-main-conference-eu-connect/)
- [Bay Area Biotech Pharma Statistics Workshop](https://mmsholdings.com/events/bay-area-biotech-pharma-statistics-workshop-2/)
- [2025 Boston Pharmaceutical Statistics Symposium](https://mmsholdings.com/events/2025-boston-pharmaceutical-statistics-symposium/)
- [The World Drug Safety Congress Americas](https://mmsholdings.com/events/the-world-drug-safety-congress-americas/)
- [12th Annual Outsourcing in Clinical Trials UK & Ireland 2025](https://mmsholdings.com/events/outsourcing-clinical-trials-uk-ireland-2025/)
- [17th Annual Outsourcing in Clinical Trials New England 2025](https://mmsholdings.com/events/17th-annual-outsourcing-in-clinical-trials-new-england-2025/)
- [SCDM 2025 Annual Conference](https://mmsholdings.com/events/scdm-2025-annual-conference/)
- [PSI 2025 Conference](https://mmsholdings.com/events/psi-2025-conference/)
- [16th Annual Outsourcing in Clinical Trials East Coast 2025](https://mmsholdings.com/events/16th-annual-outsourcing-in-clinical-trials-east-coast-2025/)
- [15th Annual Outsourcing in Clinical Trials Europe 2025](https://mmsholdings.com/events/15th-annual-outsourcing-in-clinical-trials-europe-2025/)
- [MassBio Panel on Advancing Development](https://mmsholdings.com/events/massbio-panel-on-advancing-development/): This panel-led session, brought to you by MMS and featuring Aiden Flynn, SVP Statistical Consulting, Amanda Beaster, Director Regulatory Strategy, and Ben Dudley, Chief Commercial Officer, will examine real-life design optimization case studies, including using powerful statistical simulation software like KerusCloud. The presenters will explore innovative strategies including Real-world-data (RWD) augmentation, innovative trial designs, model-informed drug development, the role of statistical simulation in optimizing the probability of success, and best-practices for Regulatory risk management when pursuing non-standard designs. At the conclusion of the panel discussion, there will be the opportunity for the audience to ask the experts their most pressing questions in an interactive Q&A.
- [ISCR Annual Conference](https://mmsholdings.com/events/iscr-annual-conference/): If you plan on attending the ​Indian Society for Clinical Research 2025 Conference in Mumbai this year, connect with MMS leaders onsite, including Arshi Ghousia, Associate Manager of Regulatory and Medical Writing, and Priya Roy, Ph.D., Team Lead in Clinical Trial Disclosure!
- [PHUSE Single Day Event](https://mmsholdings.com/events/phuse-single-day-event/)
- [PHUSE US Connect 2025](https://mmsholdings.com/events/phuse-eu-connect-2024/): MMS biometrics leaders will be on hand at the annual PHUSE US Connect 2025 conference in Orlando, Florida! Join us on-site from March 16-19 at our booth in the main hall, and fill out the form below to set a meeting with our team in advance.
- [Outsourcing in Clinical Trials New England 2024](https://mmsholdings.com/events/outsourcing-in-clinical-trials-new-england-2024/): Connect with MMS at the 17th Annual Outsourcing in Clinical Trials West Coast 2025 conference in San Francisco this February! According to event organizers, "This conference will bring leading industry professionals together to share knowledge, with a focus on collaboration, advancing clinical development and concentrating on clinical operations, innovation, and technology."
- [Linking Leaders Medical Writing Roundtable](https://mmsholdings.com/events/linking-leaders-medical-writing-roundtable/)

## Executive Leadership
- [Uma Sharma](https://mmsholdings.com/executive-leadership/uma-sharma/): Dr. Uma Sharma is a visionary drug developer recognized for her strengths in business as a national finalist and winner of the Entrepreneur of the Year award for Michigan (2020). Dr. Sharma has successfully led several global applications, including rare disease and orphan drug approvals. In collaboration with her data-focused teams, she has pioneered several new data and submission strategies, including using RWE in new drug applications.
- [Chris Schoonmaker](https://mmsholdings.com/executive-leadership/chris-schoonmaker-mph/): A biostatistician by training, Chris is an executive leader with the technical and business experience required to lead in the clinical research industry. He held executive and senior leadership roles before MMS, including management of biometrics operations as well as oversight of key customer accounts. His key strengths include his statistical and data expertise, building and maintaining required operational delivery models to ensure quality delivery, implementing effective governance to ensure successful client collaborations and relationships, and providing statistical consultation.  Throughout his career, Chris has been a statistical lead for hundreds of clinical studies, served as a voting member on data monitoring committees, and guided the statistical strategy for regulatory submissions.
- [Mohamad Zahreddine](https://mmsholdings.com/executive-leadership/mohamad-zahreddine/): As Chief Information and Technology Officer and a member of the Executive Team at MMS, Mohamad Zahreddine is responsible for overseeing the operational and strategic aspects of the company’s Technologies, Quality and Compliance, Business Process Transformation, Product Development, Information Security, and overall Governance. 
- [Evan Picard](https://mmsholdings.com/executive-leadership/evan-picard/): Evan’s leadership journey has seen him play pivotal roles in shaping business strategies across multiple industries. Before joining MMS, Evan was Vice President of Finance at Parexel, having previously made significant contributions to renowned entities such as Syneos Health, PRA Health Sciences, and RTI International. His ability to forge strong teams and provide forward-looking insights positions him as a cornerstone of MMS’s future growth.
- [Ben Dudley](https://mmsholdings.com/executive-leadership/ben-dudley/): Ben is a seasoned executive with experience gained over a 27-year career in the industry, in both the biopharma and clinical development services sectors. Ben’s deep, broad expertise spans drug development, sales and customer relationship management, operational leadership, and process optimization. He has led truly global teams and diverse delivery portfolios.
- [Michelle Gayari](https://mmsholdings.com/executive-leadership/michelle-gayari/): Michelle Gayari, Executive Vice President, Global Operational Excellence and Innovation and member of the Executive Team at MMS, leads the global technical, medical and scientific functions. She has more than 20 years of experience in clinical research, including career highlights at the Mayo Clinic and Pfizer, prior to joining MMS.
- [Prasad M. Koppolu](https://mmsholdings.com/executive-leadership/prasad-m-koppolu/): In his role as Corporate Advisor, Prasad will continue to advise on strategic direction, and optimize growth and scale across all global locations.

## Board of Directors
- [Uma Sharma, PhD](https://mmsholdings.com/board-of-directors/uma-sharma-md/): Dr. Uma Sharma is a visionary drug developer recognized for her strengths in business as a national finalist and winner of the Entrepreneur of the Year award for Michigan (2020). Dr. Sharma has successfully led several global applications, including rare disease and orphan drug approvals. In collaboration with her data-focused teams, she has pioneered several new data and submission strategies, including using RWE in new drug applications.
- [Michael Dees](https://mmsholdings.com/board-of-directors/michael-dees/): Michael leads Lindsay Goldberg’s business services vertical and its investment activities in Europe, and co-leads the industrials vertical. He has led some of Lindsay Goldberg’s most successful investments and serves on the board of directors of several Lindsay Goldberg portfolio companies, including Creation Technologies, Liveo Research, Stelco Holdings, Summit Interconnect, Galen Mental Health, and Doppler Veterinary Network. Prior to joining Lindsay Goldberg, Michael worked at Morgan Stanley.
- [Peter Nurnberg](https://mmsholdings.com/board-of-directors/peter-nurnberg/): In addition to MMS, Peter serves on the board of directors of Aspire Bakeries, and he previously served on the board of directors Big Ass Fans. Previously, he was an investor at TPG Capital, and he worked as an investment banker at Goldman Sachs.
- [Joe Avellone, MD](https://mmsholdings.com/board-of-directors/joe-avellone-md/): Dr. Avellone, is on the Boards of Directors of MMS, Apnimed, Clinical Ink, Celerion, and Biorasi. He has previously served on the Board of Cytel.
- [Ken Anhalt](https://mmsholdings.com/board-of-directors/ken-anhalt/): In addition to MMS, Ken serves on the board of directors of Doppler Veterinary Network. Prior to joining Lindsay Goldberg, Ken worked as an investor at Blackstone in New York and at Bain Capital in Boston.
- [Irving Dark](https://mmsholdings.com/board-of-directors/irving-dark/): Irving Dark is a biometrics Subject Matter Expert with over 30 years of industry experience guiding drug, biologic, and medical device products successfully through the development process. Currently, he is on the Board of Directors of MMS, Founder/Managing Director of Sun Rock Partners, and an Affiliate Partner at Lindsay Goldberg.

## Global Leaders
- [Somya Dunn, MD](https://mmsholdings.com/global-leaders/somya-dunn-md/)
- [Aiden Flynn](https://mmsholdings.com/global-leaders/aiden-flynn/)
- [Stephanie Chang](https://mmsholdings.com/global-leaders/stephanie-chang/): Consistently, Stephanie looks for innovative solutions to meet the objectives of studies and programs within a multifaceted supplier environment. Stephanie’s Project Management team is known for offering outstanding service and forging enduring partnerships with pharmaceutical and biotech firms. This includes collaborating with their development partners to promote a cohesive service delivery approach.
- [Ben Kaspar](https://mmsholdings.com/global-leaders/ben-kaspar-2/): Ben works with sponsors to plan their programs and navigate the regulatory submission process throughout the entire drug development life-cycle. Ben and team have a deep experience in regulatory science for drug/biologic development, designing innovative strategies to maximize the likelihood of regulatory approval of the target across a variety of therapeutic areas including rare diseases.
- [Sandy Robbins](https://mmsholdings.com/global-leaders/sandy-robbins/): Before joining MMS, Sandy accumulated over 18 years of experience in the CRO industry, holding various Commercial and Finance leadership roles. Her background includes expertise in developing pricing models, supervising proposal and contract workflows, optimizing CRM data structures, and crafting management reports and dashboards. Sandy’s goal is to ensure that MMS has the right processes, systems, and personnel in place to support its ongoing commercial growth and expansion.
- [Lucy Sutton](https://mmsholdings.com/global-leaders/lucy-sutton/)
- [Steve Eisenstein](https://mmsholdings.com/global-leaders/steve-eisenstein/)
- [Laura Bateman](https://mmsholdings.com/global-leaders/laura-bateman/)
- [Uma Nathan](https://mmsholdings.com/global-leaders/uma-nathan-4/): Under Uma Nathan’s leadership, MMS is able to grow its team internationally, across multiple time zones, to provide services and support on a near 24/7 clock. Her interactions with global colleagues ensure alignment across the organization maintaining MMS as the best place to work.
- [Nandini Vijaisimha](https://mmsholdings.com/global-leaders/nandini-vijaisimha-3/): Nandini Vijaisimha, with her deep-rooted expertise and passion, now stands as the Senior Director of India Corporate Affairs at MMS. In this pivotal role, she oversees and orchestrates the company’s corporate affairs strategies within the Indian context. Her activities encompass government and regulatory relations, corporate communications, and stakeholder engagement, ensuring that MMS’s values and objectives resonate in the region.
- [Diederik Van Niekerk](https://mmsholdings.com/global-leaders/diederik-van-niekerk-4/): Diederik Van Niekerk established the South African operations in 2016. He currently heads up all business operations, including human resources and finances, for the Sub-Saharan Africa and EU region(s) at MMS. In addition, he contributes to internal communications and leadership development, and cultivates the #OneMMS culture, aligning our global colleagues across the organization in the process.
- [Teresa Cesena](https://mmsholdings.com/global-leaders/teresa-cesena-3/): The medical writing and transparency teams have grown significantly under her leadership, and one of her key responsibilities has been to ensure that onboarding, training, and mentoring continue to maintain high levels of quality. Teresa oversees initiatives that enable the team to stay ahead of industry trends and regulations and is responsible for overseeing teams who can execute deliverables in a variety of models, including in FSP partnerships. In addition, she manages teams with expertise in related technologies and tech-enabled solutions, like Automatiqc® quality tool.
- [Jeffrey Wiese](https://mmsholdings.com/global-leaders/jeffrey-wiese/)
- [Venkata Atkuri](https://mmsholdings.com/global-leaders/venkata-atkuri/): As Director of Quality and Compliance, Venkata provides leadership across the entire organization on Quality and Compliance, including implementing and managing effective compliance monitoring to ensure compliance with regulations and company policies and collaborating cross-functionally impacts on compliance and efficiencies.
- [Kevin Chartier](https://mmsholdings.com/global-leaders/kevin-chartier-4/): Kevin Chartier, as Principal Advisor of Biostatistics and Submissions Planning, Kevin works with the biostatistics team across MMS global operations to support Sponsors with complex studies, programs and submissions across various therapeutic areas and extending to rare diseases. In addition, he acts as the senior technical reviewer for complex biostatistics studies and advises Sponsors on both overall and quantitative specific methods and efficiencies at the protocol and project level, leading to health authority submissions.
- [Stephine Keeton](https://mmsholdings.com/global-leaders/stephine-keeton/)

## Advisory Board
- [Philip Breitfeld, MD](https://mmsholdings.com/scientific-advisory-board/philip-breitfeld-md/): Dr. Breitfeld has led development and project teams focusing on phase 1, Proof of Concept, and Pivotal trials in oncology. He has had pharmaceutical development experience in solid tumors (CRC, NSCLC, prostate, breast, SCCHN, pancreatic, renal cell carcinoma, gastric, GBM, and melanoma) and malignant hematology, including leading oncology development at both small biotechs and midsized global pharma companies. In his four years at IQVIA (Quintiles), he developed and led the Oncology Center of Excellence- the matrix organization that drives the long-term business agenda for oncology at IQVIA.
- [Bernie Zeiher, MD](https://mmsholdings.com/scientific-advisory-board/bernie-zeiher-md/): Trained as a pulmonary and critical care physician, he has led the development of products in critical care, pain, immunology, and infectious diseases. He was involved in and oversaw the approval of over 15 products. He is passionate about addressing unmet patients’ needs in underserved and severe diseases. Dr. Zeiher has held increasing leadership and executive responsibility positions at Astellas, Pfizer and Lilly, including board memberships, CMO and President of Development.
- [Charlie Taylor, PhD](https://mmsholdings.com/scientific-advisory-board/charlie-taylor-phd/): Prior to MMS, Dr. Taylor worked at Pfizer, formerly with Parke-Davis, for more than 25 years. There, he supervised and managed a laboratory of scientists involved in early stages of drug discovery in fields that included neurological diseases, epilepsy, neuropathic pain, stroke, anxiety, sleep disorders, bipolar disorder and schizophrenia.
- [Ethan Weiner, MD](https://mmsholdings.com/scientific-advisory-board/ethan-weiner-md/): During the course of his career, Dr. Weiner has been involved in all aspects of drug and biologics development. This work spanned early and late phases of development and involved working with discovery and commercial organizations to create therapeutic area strategies, product profiles, and development plans, achieving profiles for specific molecules.
- [Maha Ghazzi, PharmD](https://mmsholdings.com/scientific-advisory-board/maha-ghazzi-pharmd/): Prior to MMS, she has worked at Pfizer, most recently as Executive Director/Development Team Leader. In this role, she was responsible for leading late stage development teams for several candidates in thrombosis (apixaban) and atherosclerosis (Biologics: HDL infusions). Dr. Ghazzi also provided cross functional leadership to develop an integrated strategy, communicate with senior management for endorsement, and ensure timely implementation of agreed plans. She worked closely with opinion leaders and experts in the field in order to ensure that the clinical development plan was optimized to meet regulatory and commercial needs. Additionally, she interacted with regulatory agencies (FDA, CHMP, and PMDA) for alignment on clinical and non-clinical development plans.
- [Elizabeth Garofalo, MD](https://mmsholdings.com/scientific-advisory-board/elizabeth-garofalo-md/): Dr. Garofalo served as Senior Vice President and Global Head of Clinical Development at Novartis from 2010 to 2016, and a member of the Novartis Global Development Leadership Team, Chair of the Novartis Portfolio Stewardship Board and Co-Head of the Novartis Neuroscience Franchise. Prior to that, she was Vice President and Head of the Neuroscience Therapy Area at Astellas. She started her career at Parke-Davis/Pfizer where she had jobs of increasing responsibility, including Ann Arbor Site Head of Neuroscience and Ann Arbor Site Head of Worldwide Regulatory Affairs.
- [Leland Loose, PhD](https://mmsholdings.com/scientific-advisory-board/leland-loose-phd/): Prior to MMS, he has worked at Pfizer, most recently as Executive Director and Site Clinical Strategic Partnerships Head. In this role, he was responsible for management of teams involved in clinical development of alliance products, including COX2s, Macugen, Indiplon, Spiriva, and Xiaflex.
- [Atul Pande, M.D](https://mmsholdings.com/scientific-advisory-board/atul-pande-m-d/): Atul Pande has a broad experience in strategic enterprise leadership of R&D with proven results as demonstrated by successful regulatory filings and approvals of new drugs.
- [Edmund Harrigan, MD](https://mmsholdings.com/scientific-advisory-board/edmund-harrigan-md/): As Senior Vice President of Worldwide Safety and Regulatory for Pfizer from 2012 to 2015, he led a 3,500-person team across 80 countries and was responsible for collecting, interpreting, and reporting clinical safety data for more than 600 marketed products, as well as managing regulatory interactions with global health agencies.
- [Bob Rappaport, MD](https://mmsholdings.com/scientific-advisory-board/bob-rappaport-md/): In 1994, after four years on the faculty at George Washington, he joined the neurology division at the FDA’s Center for Drug Evaluation and Research, where he spent the first few years developing expertise in drug regulatory science, drug product development, and clinical trial design and analysis. In 1998, Dr. Rappaport was asked to become a team leader in the FDA division responsible for the analgesic, anesthetic, and addiction drug products, an opportunity well suited to his long-standing interest in improving pain management. He was promoted to Deputy Division Director later that year and Division Director three years later. He remained in that position until he retired from FDA in October of 2014.
- [Mahmoud Ghazzi, MD, PhD](https://mmsholdings.com/scientific-advisory-board/mahmoud-ghazzi-md-phd/): Over the past 25 years, he has held several executive leadership roles that cover the spectrum of Drug Development including President, Global Development Head, Chief Medical Advisor, Medicine Development Center Head, and Therapeutic Area Head. His most recent role was President, Daiichi-Sankyo Pharmaceutical Development, and Global Development Head, Daiichi-Sankyo Research & Development.
- [Mark Fletcher, MD](https://mmsholdings.com/scientific-advisory-board/mark-fletcher/): In this role, he developed an internal immunologic safety function to globally support Pfizer’s Biotherapeutics (BioTx) programs and improve the likelihood of success as well as increase Pfizer’s external footprint as a major BioTx company; provided clinical immunology support to the therapeutic vaccines and regenerative medicine research programs.

## Ebooks
- [A Practical Guide to Expedited Regulatory Pathways](https://mmsholdings.com/ebooks/expedited-regulatory-pathways-guide/): Expedited regulatory pathways offer a powerful advantage for sponsors developing therapies that address serious or unmet medical needs. But navigating Fast Track, Breakthrough Therapy, Priority Review, Accelerated Approval, PRIME, and other accelerated options requires strategic planning, cross-functional alignment, and evidence packages that withstand rigorous scrutiny.
- [Streamline Your NDA/BLA Submission Process with Proven Best Practices](https://mmsholdings.com/ebooks/nda-bla-submission-best-practices-guide/): Submitting a New Drug Application (NDA) or Biologics License Application (BLA) is a defining milestone but for many sponsors, it’s also one of the most complex. Tight timelines, shifting data, and cross-functional dependencies can quickly lead to confusion and rework.
- [Solve Clinical Trial Complexity with Confidence](https://mmsholdings.com/ebooks/clinical-trial-complexity/): Clinical trials today are more complex than ever adaptive protocols, decentralized designs, multi-vendor ecosystems, and ever-evolving regulatory demands make efficiency a constant challenge.

## Whitepapers
- [Psychedelics, FDA Acceleration, and the Coming REMS Reality](https://mmsholdings.com/whitepapers/rems-for-psychedelic-therapies/): As psychedelic therapies move closer to regulatory decision-making, attention is increasingly shifting beyond clinical outcomes and toward the practical realities of implementation. While recent policy developments may accelerate pathways for review and engagement, they do not change the fundamental expectations for safety, risk management, and operational feasibility. These therapies will still require sponsors to demonstrate that benefits outweigh risks and for many products, Risk Evaluation and Mitigation Strategies (REMS) will play a central role in that process.
- [Estimands: Opportunity or Risk for Drug Developers?](https://mmsholdings.com/whitepapers/estimands-in-drug-development/): In today’s evolving regulatory landscape, the concept of estimands has become pivotal in aligning study objectives, design, and statistical interpretation. Yet, for many in clinical development, its implications remain complex and often misunderstood.
- [The Chief Medical Officer’s Investor Playbook](https://mmsholdings.com/whitepapers/cmo-investor-playbook/): This new eBook, The Chief Medical Officer’s Investor Playbook: Leveraging Biostatistics to Boost Fundraising Confidence, provides actionable insights to help CMOs and biotech executives de-risk their programs, build investor trust, and secure funding faster. Drawing on MMS expertise, this guide reveals strategies you can apply right now to strengthen your pitch and clinical development plan.

## Case Studies
- [Operating as an Integrated Regulatory Writing and Submission Partner for Small and Mid-Size Pharmaceutical Companies](https://mmsholdings.com/case-studies/regulatory-writing-submission-support/): MMS partners with sponsors as an extension of their organization, delivering regulatory writing, project management, submission execution, and document management support across the entire development lifecycle. Through flexible resourcing and deep regulatory expertise, MMS helps sponsors accelerate submissions, maintain compliance, and advance programs without expanding permanent internal teams.
- [Turning Regulatory Pressure into a Strategic Partnership: Public Release of Clinical Information (PRCI) for a Large Biotech Organization](https://mmsholdings.com/case-studies/health-canada-prci/): Discover how MMS delivered a fully compliant Public Release of Clinical Information (PRCI) submission in just four weeks through expert governance, operational excellence, and regulatory precision.
- [From Challenge to Confidence: How MMS Delivered 800+ High-Quality Narratives in Record Time](https://mmsholdings.com/case-studies/narrative-delivery-fsp/): Leveraging our Agile Functional Service Provider (FSP) model, MMS rapidly mobilized a cross-functional team, established strong leadership, and delivered exceptional narrative quality that exceeded expectations.
- [How MMS Modernized Pulmonary Data Models to Streamline Clinical Analysis and Improve Decision-Making](https://mmsholdings.com/case-studies/pulmonary-suite-data-models/): Pulmonary clinical programs generate large volumes of diverse and complex data—from spirometry and gas exchange outputs to patient questionnaires and longitudinal functional assessments. Without a harmonized and scalable data model, sponsors often struggle with inefficient analyses, inconsistent datasets, and delays in regulatory submissions.
- [Expert Support for Regulatory Briefing Books that Strengthen Sponsor Defense Strategies](https://mmsholdings.com/case-studies/regulatory-briefing-book-support/): Creating agency briefing books demands the highest level of scientific and regulatory rigor. For sponsors preparing for critical meetings or submissions, the ability to communicate clearly and align cross-functional inputs can determine success.
- [How MMS Scaled Biostatistics Expertise to Accelerate a High Priority Vaccine Program](https://mmsholdings.com/case-studies/fsp-biostatistics/): When tight timelines, interdisciplinary teams, and complex statistical challenges converge, having the right expertise at the right moment becomes mission critical. This case study shows how a leading pharmaceutical company partnered with MMS to rapidly onboard an experienced statistician through a flexible Functional Service Provision (FSP) model.
- [Regulatory Expertise that Strengthens Global Market Success](https://mmsholdings.com/case-studies/regulatory-writing-support/): Supporting a globally marketed product requires precision, speed, and seamless collaboration across functions. In this case study, MMS partnered with a global sponsor to deliver comprehensive regulatory writing support for a marketed multiple sclerosis (MS) therapy.
- [How MMS Supported IDMC Operations to Ensure Integrity and Safety in a High Complexity COVID 19 Trial](https://mmsholdings.com/case-studies/idmc-support/): Designed for clinical operations leaders, biometrics directors, and trial oversight teams, this overview highlights how MMS aligned with regulatory expectations, built secure unblinded environments, and delivered critical safety and efficacy outputs within strict timelines. With multiple interim analyses and fast moving study conditions, the role of a reliable IDMC support partner became essential.
- [Strengthen Early Phase Oncology Trials with Expert Biostatistical Support](https://mmsholdings.com/case-studies/biostatistics-early-phase-clinical-trials/): Early phase oncology trials require more than just statistical outputs they demand rigorous planning, adaptive thinking, and precise quantitative insight to guide development decisions. For emerging biopharma teams, having the right biostatistics partner can drastically improve efficiency, data clarity, and clinical confidence.
- [Transforming Real-World Data into Regulatory-Ready Evidence with KerusCloud®](https://mmsholdings.com/case-studies/keruscloud-real-world-evidence/): As real-world data (RWD) becomes central to modern regulatory and clinical decision-making, the challenge for sponsors lies in transforming messy, incomplete datasets into reliable, regulatory-grade evidence.
- [How One Sponsor Rescued an Underpowered Trial Using Simulation-Guided Design](https://mmsholdings.com/case-studies/clinical-trial-design-simulation/): Clinical development rarely goes as planned. When recruitment slows, assumptions shift, or new scientific insights emerge, teams must quickly determine whether their study is still designed to succeed. In this case study, you’ll see how a global sponsor confronted this challenge mid-trial and avoided costly delays and underpowered outcomes.
- [Evaluating Biomarkers with KerusCloud®: Powering Precision in Early Clinical Decision-Making](https://mmsholdings.com/case-studies/evaluating-biomarkers-keruscloud/): Biomarker evaluation plays a critical role in precision medicine yet traditional trial designs often limit early insights into predictive validity. This case study showcases how MMS leveraged KerusCloud, an advanced data simulation platform, to evaluate complex biomarker performance and guide informed trial decisions faster.
- [Build and Validate Composite Biomarkers Faster with KerusCloud®](https://mmsholdings.com/case-studies/keruscloud-composite-biomarker/): Developing predictive biomarkers is one of the most powerful and challenging — frontiers in clinical research. For GSK’s COPD clinical discovery team, identifying patients with worsening emphysema required validating a complex multivariate biomarker model under tight sample limitations.
- [Adapt Smarter with KerusCloud®: Overcome Clinical Trial Recruitment Challenges](https://mmsholdings.com/case-studies/keruscloud-adaptive-trial/): When patient recruitment slows, the risk of study delays and costly rework rises sharply. For one sponsor struggling to meet sample size targets, MMS leveraged KerusCloud®, a simulation-driven study design platform, to explore adaptive solutions that maintained trial validity and regulatory confidence.
- [Accelerate Regulatory Approval with KerusCloud® Simulation Design](https://mmsholdings.com/case-studies/keruscloud-enabling-early-drug-approval/): In today’s competitive life sciences landscape, time is the ultimate currency. For a small biotech company developing a new C. difficile treatment, traditional study designs required over 1,000 patients an impossible scenario for limited budgets and urgent patient needs.
- [How KerusCloud® Simulation Helps Biotechs Secure Faster Funding Rounds](https://mmsholdings.com/case-studies/keruscloud-trial-simulation-funding/): In the fast-moving world of clinical development, biotech innovators face immense pressure to design efficient, evidence-based studies that attract investor confidence. This case study reveals how MMS Holdings leveraged KerusCloud®, a cutting-edge simulation-guided study design platform, to help a small biotech de-risk its RSV program, optimize study designs, and accelerate funding success.
- [Accelerate Pediatric Drug Development with Bayesian Extrapolation Powered by KerusCloud®](https://mmsholdings.com/case-studies/keruscloud-bayesian-extrapolation/): Pediatric drug development is often slowed by small sample sizes, recruitment challenges, and regulatory complexity. When a global sponsor faced an incomplete pediatric study, the MMS biostatistics team used KerusCloud®, a powerful simulation-driven study design platform, to assess the feasibility and success probability of a Bayesian extrapolation approach.
- [Drive Precision Medicine Success with KerusCloud® Simulation Design](https://mmsholdings.com/case-studies/keruscloud-precision-medicine/): Designing effective precision medicine studies requires more than scientific insight, it demands foresight. For one sponsor, an Alzheimer’s disease study missed its primary endpoint, prompting an urgent need to understand how trial success could be improved.
- [How MMS Used Real World Data to Build a Validated Synthetic Control Arm for an Oncology Trial](https://mmsholdings.com/case-studies/synthetic-control-arm-rwd/): In highly targeted oncology programs where patient populations are small and randomized control trials are difficult to conduct, real world data can play a powerful role in strengthening evidence generation. This case study highlights how a biotechnology company partnered with MMS to evaluate and construct a synthetic control arm using a large real world data registry.

## Fact Sheets
- [Advance Psychedelic Drug Development With Proven Regulatory and Data Expertise](https://mmsholdings.com/fact-sheets/psychedelic-drug-development/): Psychedelic drug development is entering a critical phase as regulatory expectations evolve and clinical programs scale across compounds such as MDMA, ketamine, and psilocybin. While the therapeutic promise is significant, sponsors face unique challenges in trial design, safety oversight, and regulatory engagement that demand specialized expertise.
- [Agile Medical Writing Staff Augmentation When You Need Expertise Not Headcount](https://mmsholdings.com/fact-sheets/medical-writing-staff-augmentation/): In today’s unpredictable clinical development environment, research teams are under constant pressure to move faster, often without the ability to increase permanent headcount. When workloads spike or priorities shift, delays in medical writing can quickly put programs at risk.
- [Biometrics Solutions Fact Sheet: End-to-End Data Expertise for Complex Clinical Trials](https://mmsholdings.com/fact-sheets/biometrics-services/): This fact sheet provides a clear, practical overview of MMS’s biometrics capabilities, covering data management, biostatistics, statistical programming, trial design, and regulatory submissions.