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

  • Jul 16 2021
  • Length: 30 mins
  • Podcast

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

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  • Summary

  • 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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