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Trial Master File + Clinical Document Management Conference

June 11-13, 2019  |  Philadelphia, PA

 

Maintaining compliance and accuracy during the development of data and information associated with clinical trials.

Learn more >

 

Join Avoca for the following session:

Panel: Ensuring Constant Inspection Readiness – Where Good Clinical Practice and Good TMF Practice Intersect

  • How should you handle a TMF that is stored in a variety of systems at different locations and still maintain a culture of inspection readiness?
  • How can clinical operations professionals utilize the TMF to demonstrate ICH E6 (R2) compliance by using, and appropriately archiving, GCP tools?
  • How can clinical operations professionals take a risk-based approach to managing the expected completeness of a TMF?
  • How can organizations use IR tools and appropriately file these in the TMF to be inspection ready according to risk appetite?
  • What TMF-specific practices can ensure smooth inspection-day logistics and how can you ensure a high-quality TMF throughout the life of a trial?

 

 

Moderator: Kristen Jonathan Bennett, Associate Director, Client Delivery, The Avoca Group

Kristen Jonathan Bennett is a member of the Avoca Group’s integrated consulting and Avoca Quality Consortium® workstreams. Kristen provides consulting services to top pharmaceutical, biotech, and contract research organizations, and oversees client deliverables, systems, and processes across company. She has 12 years of clinical trial experience with expertise in clinical trial execution, process development, and strategic management. Her previous professional roles include project, data, and site management. Kristen holds a bachelor’s degree in Biology from Kutztown University of Pennsylvania.

 

Additional information and registration for this event will be available soon.