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From SOP creation to a study’s start-up and archival, the trial master file (TMF) plays an important role in a clinical trial. It should come as no surprise, then, that TMF professionals face a number of challenges in relation to creating an oversight plan, ensuring quality and implementing metrics.

Many organizations are still creating TMF standard operating procedures to guarantee the quality and accuracy of the TMF. During clinical trials, project teams are responsible for numerous tasks — and filing clinical materials into the TMF may not always be their top priority. Additionally, they may not formally turn their attention to TMF quality control until well after study closeout, which makes it more difficult to resolve any documentation gaps they identify. This process also becomes more challenging when you add in CROs and a number of clinical research sites.

Now in its sixth year, ExL Pharma’s European Trial Master File Summit — convening 16-18 October 2017 in London, UK — will continue to provide an educational platform for professionals to explore best practices to ensure TMF completeness and inspection readiness through streamlined document management and a defined SOP, metrics and a governance structure.

At the 7th Trial Master File Summit, 40+ speakers will share best practices on a wide range of topics including:

Top Five Reasons to Attend

  1. Enhance the quality of your TMF by creating and defining roles for stakeholders, implementing metrics, developing an inspection readiness platform, and improving governance of vendors
  2. Understand how to best prepare for inspections from all regulatory authorities
  3. Explore all the options when using a CRO’s or sponsor’s eTMF
  4. Ensure efficiency with an interoperability strategy
  5. Network with more than 150+ global TMF professionals


“[This is the] best European TMF conference where you can learn everything from CRO/sponsor issues, TMF QC techniques and eTMF/TMF readiness while being surrounded by more than 100 TMF professionals.”

“Great sessions on R&D budgets, Brexit and TMF compliance with regulations.”

“Great sessions on timely submissions, complete TMFs and inspection readiness.”

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