In this episode, our experts will be diving into QbD and how this proactive approach is shaping clinical trial management. From ensuring compliance to improving overall trial efficiency, we’ll explore why embedding quality from the start is critical for clinical success.

Joining us for this discussion is our President & CEO, Paul Fenton-Carter, and our Head of eTMF Services, Donatella Ballerini. Together, they’ll break down how QbD principles can enhance TMF quality, reduce risks, and future-proof trial documentation.

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CHAPTERS:

00:00 Hot Take w/ Paul Fenton-Carter

00:40 Speaker Intros

01:39 It's a Jurassic World when it comes to quality (topic intro)

05:32 The importance of quality in clinical trials

08:58 Processes (SOPs) for quality

14:45 How to define the list of essential records?

19:22 Where QMS meets TMF & SOP

33:20 Agile TMF vs the current TMF situation

33:04 Benefits of the integration, Manual integration and the future

41:03 QbD is a mindset not just a methodology & questions

49:24 Sign up for TMF Week 2025 & wrap up

52:11 Outro

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