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DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.

The Letter and Spirit of Risk-Based Monitoring: How to Creatively Implement Risk-Based Modeling and Unlock the Potential of the Team

    Session Chair(s)
      Teresa  Ancukiewicz, MA

      Teresa Ancukiewicz, MA

      • Senior Manager, Clinical Data Management
      • Boston Scientific Corporation, United States
    This session will focus on real-life experiences with risk-based monitoring (RBM) implementation and share lessons learned on how RBM principles were adapted to the realities of the company structure and innovative approaches that go beyond large-pharma RBM models. Presenters will review their journey to obtain meaningful analytics, key risk indicators and thresholds,mitigation actions,workflow management, and how the new process impacts the actual risk identification and management. The session will explore how the RBM process works in the outsourcing model, and how it impacts CRO oversight and provide updates from TransCelerate, including lessons learned from RBM implementations, best practices for adoption, and post-adoption metrics and observations.
    Learning Objective : Discuss options for creative implementation of risk-based monitoring processes; Examine the correlation between the risk-based monitoring KRIs and existing metrics; Discuss the impact on roles and opportunities for clinical data management with the adoption of risk-based monitoring.
      Teresa  Ancukiewicz, MA

      Creative Implementation of Risk-Based Monitoring by Unlocking the Potential of Study Team

      Teresa Ancukiewicz, MA

      • Senior Manager, Clinical Data Management
      • Boston Scientific Corporation, United States
      Johann  Proeve, PhD

      Risk-Based Study Management: From Risk Identification to the Study Closure for In-House and Outsourced Studies

      Johann Proeve, PhD

      • Chief Scientific Officer
      • Cyntegrity , Germany
      Suzanne  Lukac

      Best Practices and Observations from Implementing TransCelerate’s Risk-Based Monitoring Model Framework

      Suzanne Lukac

      • Director, Global Monitoring Excellence, Risk-Based Monitoring Implementation
      • Merck & Co., Inc., United States