ExL Pharma’s 2nd Trial Master File Summit brought together Clinical Research, TMF, Data Managers, Document Managers, Records Managers and Quality Assurance professionals from 47 different organizations to share their best practices to maintain good record keeping dedicated to TMF filing.

This meeting featured over 18 one-of-a-kind sessions, panel discussions and an interactive pre-conference workshop. Some of the exciting topics presented were:

  • Providing TMF content during a health authority inspection
  • Best practices in managing clinical trial documents
  • Managing TMF quality
  • Tackling the eTMF challenges
  • Coordinating a TMF system between a sponsor and CRO
  • Exploring technology developments for choosing a TMF filing platform

This year brought together an amazing group of professionals committed to in-depth conversation and knowledge sharing of TMF both in the presentations room and the exhibition hall.

Look for these upcoming TMF events:

2nd European Trial Master File Summit this October in London, UK

3rd Trial Master File Summit next January in Arlington, VA

sceneClockwise, from top left: Andrew Waite (Director, Records and Information Management, Amgen) speaks about “Reducing Clutter While Retaining Essential Paper Documents”; Conference Chairs Ivan Walrath (Trial Master File Process Owner, Pfizer), Keith Davis (Global Director & Head, R&D Records Management, Biogen Idec), and Karen Redding (Global Business Development Director, Phlexglobal) giving their opening remarks; Jamie Toth (eTMF Lead, Associate Director, Covance) and Sharon Ames (Enterprise Program Director, NextDocs) give a talk on “An Inside Look at Successfully Implementing an eTMF System within a Global CRO”; Yong Guo, MD (Clinical Operations 2, Mitsubishi Tanabe Pharma Development America, Inc.) and Karen Redding (Global Business Development Director, Phlexglobal) in the exhibit hall; Left to right: Keith Davis (Global Director & Head, R&D Record Management, Biogen Idec), Kimberly Fowler (Associate Director, Clinical Operations, Intercept Pharmaceuticals), and Charles Romano (Director of Clinical Development & Regulatory Affairs, Aderans Research Institute); The opening remarks to the pre-conference workshop on “Providing TMF Content during Health Authority Inspections – Considerations for the Development of the Complex Process.”



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