SOLUTIONS

Comprehensive Safety & Risk Management

Pharmaceutical companies trust MMS with their drug safety and pharmacovigilance needs from Phase 1 through post approval.

MMS has been absolutely wonderful in the development of our safety documents. True professionals, very knowledgeable, and just honestly amazing.

Top 10 Pharma

Head of Safety

MMS has the right expertise, tools, and technologies to oversee all aspects of Pharmacovigilance, Safety, and Risk Management throughout your product development lifecycle. Our global team understands the regional nuances and changing regulatory requirements, as we submit to the US FDA, EMA, and 25+ other global health authorities annually. With our expert team, MMS provides comprehensive Pharmacovigilance services tailored to your specific needs through the drug development process.

Our Pharmacovigilance (PV) team will serve as an extension of your PV department. Starting in early development, MMS will build compliant expedited reporting processes, monitor for safety signals, and prepare all documents to meet regulatory reporting requirements.

MMS understands that as your development program progresses additional data sources such as Real World Data (RWD), Real World Evidence (RWE), and patient perspectives may be used to characterize differentiators for your product. Accordingly, MMS will customize the strategy to suit the needs of your program as it achieves key milestones. Then, we will work with you to review the data and to understand the emerging benefit-risk profile through a structured benefit-risk assessment which will help your organization make informed investment decisions.

Continuing into peri- and post-approval activities, our team of experts can help you define and manage your post-market risk management strategy. Our teams are experts in planning, developing, and managing a variety of Risk Evaluation and Mitigation Strategies (REMS) including program management and coordination of shared system REMS across a set of companies.

The figure below details where, when, and how MMS comprehensive safety experts provide support.

Risk Evaluation and Mitigation Strategy (REMS)

Choosing the right partner for your REMS support is crucial to ensure compliance with FDA requirements and to effectively manage the safety profile of your drug. This allows you to focus on bringing your drug to market safely and efficiently. Let MMS help you navigate the complexities of REMS and achieve regulatory success.

MMS is the right clinical research organization (CRO) for your REMS support or to act as a program manager for shared REMS for the following reasons:

Deep Expertise

With years of experience navigating the complex landscape of FDA REMS requirements, our team of safety and regulatory specialists understand the intricacies of the essential, and often misunderstood, REMS components. MMS has a proven track record of developing and implementing successful REMS programs for clinical trial sponsors of all sizes. Additionally, our deep understanding of FDA expectations ensures that your REMS program will meet regulatory standards the first time, while efficiently mitigating risks associated with your drug.

Customized Solutions

Recognizing that no two REMS programs are identical, MMS offers tailored solutions that address the unique safety risks of your specific drug. Our personalized approach ensures that every aspect of your REMS program—from the development of the REMS materials to the REMS Assessment Plan—is meticulously crafted to suit your specific needs. This customization not only enhances the effectiveness of the program but also streamlines the compliance process.

Comprehensive Support

MMS provides comprehensive REMS support, from the initial development phase through ongoing implementation, management, and assessment. Our services include the pre-approval support for FDA meetings and negotiations as well as support for REMS modifications or revisions. By partnering with us, you gain access to a full spectrum of services designed to ease Sponsor burden and ensure seamless program execution.

Commitment to Quality

Our commitment to quality is unwavering. MMS has been ISO:9001 certified since inception and we employ rigorous monitoring and evaluation systems to ensure that all REMS components are functioning as intended and are in full compliance with FDA requirements. Our proactive approach helps prevent potential FDA observations and ensures that your drug’s safety profile is continuously managed and optimized.

Why MMS is the right choice for safety support

Nearly 70% of our experts hold a Master’s or Doctorate level degrees. We pride ourselves in our industry-leading low attrition rates. So, we can provide you with tenured experts that offer greater continuity and understanding of the intricacies of your program.
Safety is what we do! Annually, MMS produces thousands of CSR narratives, hundreds of Risk Management Plans (RMPs) and Periodic Aggregate Safety Reports (PASRs)), and numerous other documents including, REMS Assessment Reports, Benefit-Risk Assessments, and post marketing requirement studies.
We embrace and build the right technology to maintain the highest levels of innovation, like PVantage, which allows drug safety teams to collect, review and report adverse drug reactions and other safety events during a clinical trial or post market surveillance.