On the Frontlines of Clinical Operations

P7 Bringing the TMF In-house: Operations & Inspection Readiness


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Welcome to the final episode in our series: Bringing the TMF In-House, a guide to help sponsors understand what's involved with bringing the management of the trial master file in-house and how they can do it successfully.

In our final episode, Janine and Ken talk about managing the TMF on-going and how to prepare for inspection readiness. Topics include:

  • Do you need eTMF software to get inspection-ready?
  • What is a reactive approach to inspection vs a readiness approach
  • Tips for ongoing management of the TMF, including what to watch for
  • We hope you enjoyed this series and we would love to hear what you thought about the series. Drop us an email and share your thoughts!

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    On the Frontlines of Clinical OperationsBy Agatha Life Inc.