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Regulatory Submissions, Information, and Document Management Forum

Session 3 Track 3: eTMF Interchange: The Cross-Roads Between Sponsor, CRO, and Vendors

Session Chair(s)

Jamie  Toth, MS

Jamie Toth, MS

  • Global Head, TMF
  • Beigene, United States
The Clinical trial landscape is ever changing and the growing pressure to reduce the costs of clinical trials means there are more Sponsors that look to outsourcing functional areas of trial conduct. This outsourcing strategy introduces greater complexity in the management and oversight of clinical trial documentation and how it is managed within the Trial Master File (TMF). Growing regulatory pressures are also driving a great degree of focus, not just on the documentation itself, but the additional metadata fields on its authoring content and finalization. The paradigm is shifting from TMF being seen as a document repository to being a data repository that contains clinical trial documentation. Transfer processes of TMF must then address the complexity of trial documentation data and its content.

This session is aimed at discussing:
  • Hot topics in TMF for 2017
  • Inclusivity: TMF requirements and challenges faced in Sponsor, CRO and Vendor partnerships
  • Flexibility: When and if interchange is necessary
  • Case Study: Experience highlighting interoperability
  • Discussion: Interactive session from Sponsor/CRO on day to day challenges of managing multiple eTMF platforms
Learning Objective : Be informed of the newest TMF management process trends Evaluate the relevance of the topic for utilization with own company’s TMF management process Participate in sharing how the TMF management trends are being implemented across the industry


Lisa  Mulcahy

TMF Topics – What’s HOT This Year and Why YOU Should Care!

Lisa Mulcahy

  • Owner, Principal Consultant
  • Mulcahy Consulting, LLC, United States
Jamie  Toth, MS

Sponsor/CRO Case Study on Working Together and Overcoming Challenges

Jamie Toth, MS

  • Global Head, TMF
  • Beigene, United States
Gareth  Sully, PhD


Gareth Sully, PhD

  • Vice President, Site Startup and Regulatory
  • INC Research, United Kingdom
Paul  Fenton, MBA

Interoperability Case Study

Paul Fenton, MBA

  • CEO
  • Montrium, Canada