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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)
Trial Master File 2.0 – What’s Next? The Sponsor Perspective
Joanne Malia, MS, MSc
Regeneron Pharmaceuticals, United States
Director, Development Records Management
View From an eICF
Eric Delente, MA
Self-employed, United States
Consultant
Essential Document Integration: IRB and Site Perspective
Adam Roth
Schulman IRB, United States
Director, Operations
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