real world evidence rwe real world data rwd webinar programmers drug development Wisdom from the Front Lines of Successful NDA Submission Statistical Clinical Programming biostatistics cro mms holdings vendor services pharmaceutical industry biotech

MMS is proud to present our latest webinar – Wisdom from the Front Lines of Successful NDA Submission Programming: Utilizing the Biometrics Operational Data Model.

In this free, on-demand webinar you will discover:

  • The Biometrics Operational Data Model and explain how submission work can be streamlined across programmers and statisticians
  • Validation needs within a submission
  • The importance of reviewer’s guides and when they should be built
  • Why the NDA submission should be considered during early phases
  • Trial domains and how they relate to SDTM, ADaM, and TLFs
  • Items that are easy to overlooked during submission planning

Panelists include:

  • Jim Bademian, Global Head of Statistical Programming, MMS, North Carolina
  • Susheel Arkala, Principal Clinical Programmer and Associate Manager of Programming, MMS, Oregon
  • Chris Hurley, Senior Manager of Global Data Operations, Standards and Systems, MMS, Michigan

View the webinar here

Wisdom from the Front Lines of Successful NDA Submission Programming mms holdings webinar pharma cro biostatistics clinical statistical

Run time: 40:47

Suggested For You

perspectives

November 21st, 2024

Essential Nonclinical Strategies for Cell and Gene Therapy (CGT) Success

perspectives

November 12th, 2024

REMS Logic Modeling: Applying FDA Guidance from November 2024 CDER Webinar

perspectives

November 6th, 2024

How to Successfully Manage Rescue Studies and Turn Around Clinical Trials Facing Failure

perspectives

October 29th, 2024

Why Outsourcing QC of Regulatory and Medical Writing Documents is a Competitive Advantage for Large Pharma Companies

perspectives

October 22nd, 2024

Choosing the Right Clinical Trial Design: A Crucial Step in Protocol Development

perspectives

October 15th, 2024

Putting the Action in Diversity Action Plans and the Real-Time Data Visualization Technology Needed to Ensure It Happens

perspectives

October 8th, 2024

Diversity Action Plan Guidance Part I: Implications for Sponsors

perspectives

September 30th, 2024

Meet the Leaders Driving MMS’s European Growth

perspectives

September 30th, 2024

The Future of Data Management and Biostatistics: Trends and Technologies Shaping the Industry

perspectives

September 24th, 2024

Embracing Quality Management Maturity (QMM) at the Cornerstone of the Pharmaceutical Industry

perspectives

September 11th, 2024

From Historical Precedent to Modern Approvals: Lessons Learned on OTC Drug Products for FDA OMORs

perspectives

September 4th, 2024

Email Security – Navigating Through the Process of Validation and Compliance with Healthcare Business Stakeholders