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Avoiding Failure When Migrating to a New eTMF

In theory, the Trial Master File (TMF) is a collection of documentation that tells a cohesive story. But all too often sponsors are left piecing this story together retroactively due to disjointed site and sponsor systems, outsourced TMF management, and traditional processes.

With drug/device development competition and increased compliance scrutiny, emerging biotechs and device sponsors are adopting eTMFs built specifically for them – replacing outsourced eTMFs, spreadsheets, and shared drives.

Whether you’re considering an eTMF or want to ensure your strategy is effective, join Sholeh Ehdaivand, President and CEO of LMK Clinical Research Consulting, and the expert eTMF team at Florence as they:

Uncover core considerations and best practices for streamlined in-house eTMF management

Highlight how to remove the distractions from the scope of your eTMF (artifacts and processes you don’t need) and create scalable success- Discuss common eTMF findings and failures and how to avoid them

Reveal change management tips and set your team up for success

Explain how active eTMF management is essential