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Wednesday, June 21 • 2:00pm - 3:15pm
#338: Risk-Based Monitoring: Convergence of Technology, Processes, and People

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Real-life challenges and lessons learned. Impact on traditional roles, new opportunities, cross-functional collaboration, identifying data trends and issues.

Learning Objectives

Define key challenges in RBM implementation; Describe how processes and roles need to change in the organization to support the RBM; Demonstrate how results from analytics can be turned into actionable items to mitigate risks.


Mary Arnould, BSN, MSN


Five Years of Global Risk-Based Monitoring Implementation: Where We’ve Been and Where We’re Going - Best Practices and Lessons Learned
Mary Arnould, BSN, MSN

Risk-Based Monitoring Centralized Monitoring: What's Needed to be Effective?
Stephen Young, MSc

The Evolving Area of Central Monitoring: What is it? What Data is Being Reviewed? Who is Responsible?
Keith Dorricott

avatar for Mary Arnould

Mary Arnould

Business Partner, Monitoring Excellence, Bristol-Myers Squibb
Mary has been in the pharmaceutical industry for over 20 years. She began her career as a site monitor and monitored studies in numerous therapuetic areas. Mary managed site monitors for over 10 years. She has been supporting the implementation of Risk Based Monitoring at Bristol... Read More →

avatar for Keith Dorricott

Keith Dorricott

MCC Ambassador; Director, Dorricott Metrics and Process Improvement Ltd.
Keith Dorricott is Director, Dorricott MPI Ltd. and a Ambassador for the Metrics Champion Consortium. He has a background in manufacturing from Kodak Ltd. He has worked in quality, metrics, process improvement and operational roles over 11 years for two major CROs. He is a Master... Read More →
avatar for Stephen Young

Stephen Young

Chief Scientific Officer, CluePoints
As Chief Scientific Officer for CluePoints, Steve oversees the research and development of advanced methods for data analytics, data surveillance and risk management, along with providing guidance to customers in RBQM methodology and best practices. Steve worked for three bio-pharmaceutical... Read More →

Wednesday June 21, 2017 2:00pm - 3:15pm CDT
N226 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  01: Data-BigData-eHealth, Session