How CROs and Sponsors Improve TMF Management with a Shared eTMF
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How CROs and Sponsors Improve TMF Management with a Shared eTMF
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The Trial Master File (TMF) is the repository for all essential documents supporting a clinical trial. But its role is going beyond a simple storage container for files, as CROs and Sponsors work together to manage not only the collection of TMF documents but also the review and inspection processes, both internally and externally.
In this episode, Agatha’s Head of North American Operations, Ken Lownie, and Kari Brown, Director of Clinical Operations, DZS Clinical Services, discuss:
- The role of the TMF and how it is evolving
- Why CROs and Sponsors need to work together to manage the TMF successfully
- How the right eTMF enforces process coordination and collaboration
- The key features of a modern eTMF application
- How to build a shared responsibility model for the TMF
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