eTMF Bootcamp Series On-Demand

 Session 1 

TMF Fundamentals & TMF Management Best Practices

Hosted by Donatella Ballerini and Lindsay Curran from, this session covers the essentials of building and maintaining a compliant, inspection-ready TMF.

3 things you'll take away:

  • What makes a TMF inspection-ready
  • How to use the TMF Reference Model
  • Why a TMF plan is non-negotiable

Download the slide deck for Session 1

 Session 2 

Master the Regulation: A Crash Course in TMF Regs, Standards & Models

In this session, we break down the regulatory landscape governing TMF management across the major health authorities, and what it means for your day-to-day processes.

3 things you'll take away:

  • The regulatory framework you need to know
  • People are your biggest compliance risk
  • Your eTMF must be purpose-built

Download the slide deck for Session 2

 Session 3 

TMF Fundamentals & TMF Management Best Practices

Hosted by Donatella Ballerini and Lindsay Curran from, this session covers the essentials of building and maintaining a compliant, inspection-ready TMF.

3 things you'll take away:

  • What makes a TMF inspection-ready
  • How to use the TMF Reference Model
  • Why a TMF plan is non-negotiable

Download the slide deck for Session 3

 Session 4 

Agile TMF: The Data-Driven TMF Process of the Future

Hosted by Donatella Ballerini and Paul Fenton (CEO, Montrium), this session challenges the industry's most persistent misconception about TMF and makes the case for a fundamentally different way of managing clinical documentation.

3 things you'll take away:

  • Your TMF is not an archive, stop treating it like one
  • Manage the full document lifecycle inside your eTMF
  • Your TMF is a goldmine of data

Download the slide deck for Session 4

 Session 5 

TMF Migration Concierge: Using AI to Improve TMF Quality

Hosted by Paul Fenton (CEO, Montrium) and Mike Zvetko (Chief Innovation Officer, Montrium), this session closes out the Boot Camp series with a look at where TMF management is headed, and how AI is already changing the way teams index, review, and quality-check their documents.

3 things you'll take away:

  • How AI can do the heavy lifting on document indexing and QC
  • Confidence scores and risk levels determine how much human oversight is needed
  • AI turns your TMF into a data source, not just a document store

Download the slide deck for Session 5

 

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