From Transactional Support to Trusted Partnership: Achieving TMF Excellence Together

About this session

Part of Session 3, Track E: Site, Sponsor & Service Provider Partnerships (Chair: Sarah Dean, Precision for Medicine).

Building an inspection-ready Trial Master File requires strategic partnership, not reactive remediation. In this joint presentation, Intellia Therapeutics and Phlexglobal share real-world insights on cultivating successful sponsor-provider TMF partnerships across the full study lifecycle.
The session explores how early alignment on governance, accountability, and shared ownership , supported by joint oversight committees, RACI frameworks, and measurable SLAs and KPIs , establishes inspection readiness from Day 1. Grounded in the TMF Reference Model and aligned with ICH E6(R3), FDA 21 CFR Part 11, and EU Annex 11, these frameworks drive transparency and confidence throughout study execution.
Attendees will learn how effective eTMF configuration, study-specific TMF Plans, and continuous completeness monitoring support consistent performance , even amid migrations, system upgrades, and inspection surges. The presentation concludes by demonstrating how true TMF partnerships evolve beyond vendor delivery into strategic alliances that reduce risk and accelerate innovative therapies to patients.

Speakers

• JB

  Jared Brooslin

  Intellia Therapeutics

  Speaker

• SP

  Seth Pearl

  Phlexglobal

  Speaker