Blog

Webinar: Wisdom from the Front Lines of Successful NDA Submission Programming

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

< Back to MMS Blog