Nailing TMF Management Success with Your CRO Partnership

Session details:

Why Defining Roles Isn’t Enough—And What You Must Align on from Day One

A well-defined scope of work is just the starting point. To truly ensure Trial Master File (TMF) management success throughout the study lifecycle, sponsors and CROs must go deeper—aligning early on the specific TMF processes, ownership, and expectations. This presentation will highlight common pitfalls, share real-world lessons, and outline the critical TMF topics to address at clinical study kickoff to build a strong, proactive partnership that drives inspection-readiness and long-term success.