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Quality by Design: Bridging the TMF - Quality Gap in Your Study
Manage episode 478681319 series 3472771
Montrium에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 Montrium 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.
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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25 에피소드
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