Quality by Design: Bridging the TMF - Quality Gap in Your Study

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.-------------------------------------CHAPTERS:00:00 Hot Take w/ Paul Fenton-Carter00:40 Speaker Intros 01:39 It's a Jurassic World when it comes to quality (topic intro)05:32 The importance of quality in clinical trials08:58 Processes (SOPs) for quality14:45 How to define the list of essential records?19:22 Where QMS meets TMF & SOP33:20 Agile TMF vs the current TMF situation 33:04 Benefits of the integration, Manual integration and the future41:03 QbD is a mindset not just a methodology & questions49:24 Sign up for TMF Week 2025 & wrap up52:11 Outro----------------------------------------Sign up to TMF Week 2025: https://www.tmfweek.com/Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/Join us on Facebook: https://www.facebook.com/Montrium/