Day 4
May 18, 2023
11:00 am

TMF Training: Designing an Agile Approach to TMF for Inspection Readiness

If you consider your TMF only as the official repository of the essential documents of your clinical trial, you are further away than you think from being Inspection Ready.

About this session

If you consider your TMF only as the official repository of the essential documents of your clinical trial, you are further away than you think from being Inspection Ready. At Montrium, we encourage and support the active management of the TMF, making it the final deliverable of the clinical trial and ensuring that it's not only documents that tell the story but also data able to drive your business making more informed decision.

In this session we are going to cover:

  • The process as a TMF pillar
  • Different level of QCs (Doc QC, Cross Checks, Oversight, Health Check)
  • Measure your TMF (metrics, KPIs, data)
  • Use risk to be Inspection Ready
  • What’s your maturity level in TMF management?

5
Days
25
Talks
30+
Speakers
20
hours of fun
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