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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
Associate Director
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.
Speaker(s)
Creative Implementation of Risk-Based Monitoring by Unlocking the Potential of Study Team
Teresa Ancukiewicz, MA
Boston Scientific Corporation, United States
Associate Director
Risk-Based Study Management: From Risk Identification to the Study Closure for In-House and Outsourced Studies
Johann Proeve, PHD
Cyntegrity, Germany
Chief Scientific Officer
Best Practices and Observations from Implementing TransCelerate’s Risk-Based Monitoring Model Framework
Suzanne Lukac
Synchrogenix, a Certara company, United States
Associate Principal Medical Writer