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#30: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model


  • Mary  Arnould, BSN, MSN

    Mary Arnould, BSN, MSN

    • Director, Clinical Science Operations
    • Astellas Pharma Global Development, Inc., United States

    Mary is Director, Clinical Science Operations and RBM Lead at Astellas. Her pharmaceutical career spanning over 25 years has included site monitoring, site monitoring management, development of technology and process solutions for site monitoring execution and leading RBM implementation efforts. She has been involved in RBM implementation at two pharma companies focusing on process refinement, technology deployment, and change management.

  • Esther M. Huffman, MA

    Esther M. Huffman, MA

    • Associate Director, Monitoring Excellence
    • Bristol-Myers Squibb, United States

    Esther is an Associate Director in the Monitoring Excellence Group at Bristol-Myers Squibb, where she has spent the past several years developing and operationalizing the Risk-Based Monitoring methodology. In her current role, Esther facilitates the changes in technology, process, and monitoring support to embed RBM at BMS. Esther has 20 years’ experience in clinical trials, with a focus in site monitoring and the evolving Site Monitor role.

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