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Session 9 Track 3: NextGEN TMF Management Panel– Data is the Key

Session Chair(s)

Karen  McCarthy Schau

Karen McCarthy Schau

  • Director, Global Clinical Operations
  • Vertex Pharmaceuticals, United States
Our panel of TMF experts share their vision of successfully managing your TMF in the age of data and what it takes to survive and thrive in an inspection. From hearing about how using a Risk-Based approach to efficiently manage your key content and minimize the inspection scramble, to using Machine Learning for document identification and filing, your TMF process will benefit from the hard-won knowledge and experience of the panel.
Learning Objective : After attending the presentation, participants will be able to: 1. Identify TMF management problems that machine learning (ML) can help solve today. 2. State how the TMF Exchange Mechanism Standard could extend current ML capabilities. 3. Recognize how greater metadata standardization and ML could benefit TMF management industry-wide.


Marion  Mays

How Risk-based Quality Control in a Trial Master File Improves Quality While Reducing Effort

Marion Mays

  • VP, BD Expert Solutions and Consulting
  • Phlexglobal Inc, United States
Ken  Keefer, MBA, PMP

Machine Learning and TMF Management: Evolving to Data-Driven Processes

Ken Keefer, MBA, PMP

  • Principle Consultant
  • Keefer Consulting Inc, United States
Paul  Fenton, MBA

Leveraging Technology for Preparing for and Surviving Remote TMF Inspections

Paul Fenton, MBA

  • CEO
  • Montrium, Canada