How does the eTMF of the future look and function?

Download this presentation to understand how standards, technology and the regulatory requirements are effecting the evolution of the eTMF as we know it...

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Traditionally the TMF has been considered a collection of documents that needed to be collated as part of the regulatory requirements of a clinical study. Although this continues to be the case, the increasing use of electronic trial master files and more integrated clinical systems offers us new opportunities for a more holistic and real-time view over clinical trial activities. 

In this presentation we dive into the current insights and future trends in the adoption and popularity of eTMF solutions.

The presentation covers:

  • Why Still Paper?
  • Why the regulators are going electronic
  • Regulatory principles
  • What is clinical trial information?
  • High level regulatory requirements
  • High level sponsor requirements
  • The federated eTMF
  • Technical Challenges
  • 3 key enablers for the future
  • Clinical Data Warehousing could be a solution
  • Calculating eTMF completeness
  • Emerging Standards
  • How will the eTMF interchange work?
  • The 21st Century eTMF