Host Paul Fenton-Carter of Montrium is joined by Jamie Toth of BeiGene and Matt Lowery of The Pathways Group, two key contributors deeply involved in shaping this groundbreaking project. Together, they explore the progress made so far, the challenges faced, and what the future holds for the ISF Reference Model. From aligning global teams to addressing practical implementation hurdles, this episode offers valuable insights for anyone invested in improving clinical trial documentation practices.

CHAPTERS:

00:00 Hot Take w/ Matt Lowery

00:35 Guest intros (Jamie Toth and Matt Lowery)

01:55 Topic Intro & History of ISF

04:20 ISF Initiative Overview and Timeline

10:32 ISF Facts

12:28 ISF Structure

21:09 A snapshot of final draft of the ISF Reference Model

22:39 Quiz Time

23:38 Final draft snapshot continued

25:25 Matt's take on packages and sub-packages

26:24 How does the TMF Reference Model align with the ISF

29:30 The three additional ISF artifacts

34:09 ISF Initiative ongoing and future activities & questions

48:51 Wrap up and final thoughts

50:49 Outro

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Connect with Host and Guests:

Paul Fenton-Carter: https://www.linkedin.com/in/paul-fenton-carter-360b531/

Jamie Toth: https://www.linkedin.com/in/jamie-marie-t-759772/

Matt Lowery: https://www.linkedin.com/in/mattlowery/

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