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
Run time: 40:47
