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Session 6 Track 3 - Trial Master File 2.0...What’s Next?
Session Chair(s)
Betsy Fallen, RN
Consultant, BAFallen Consulting LLC, United States
The efficiency and importance of the eTMF is being driven by influences such as the implementation of the TMF Reference Model and guidance from regulatory agencies on their expectations for inspections. What is next for the eTMF? Digitizing, storing, and archiving clinical site documents is the next horizon. The intersection of digital documents and technology solutions is expected to enhance compliance, inspection readiness, and patient safety. The anticipated benefits and challenges of the eISF will be presented by three stakeholders as an eConsent form will be tracked from creation through review and upload to an inspectable repository.
Speaker(s)
Joanne Malia, MS, MSc
Director, Development Records Management, Regeneron Pharmaceuticals, United States
Trial Master File 2.0 – What’s Next? The Sponsor Perspective
Eric Delente, MA
Consultant, Self-employed, United States
View From an eICF
Adam Roth
Director, Operations, Schulman IRB, United States
Essential Document Integration: IRB and Site Perspective