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Sunday, June 18 • 1:00pm - 4:30pm
#34: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model

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Component Type: Tutorial
CE: CME 3.25; IACET 3.25; RN 3.25

The current clinical trial climate demands that sponsors find ways to reduce clinical trial complexity, drug development costs, and get more value from R&D budgets. Risk-based monitoring (RBM) allows organizations to target site monitoring activities for which risks can be best managed and deliver the greatest benefit to the study, and to become more effective and efficient in using resources, while increasing quality and patient safety. Participating TransCelerate Member Companies came together in 2012 to establish a model approach to high-quality RBM. To date, this effort has published a position paper on risk based monitoring, as well as several articles focused on sharing advancements, best practices and lessons learned from member companies adoption experience, all of which are publicly available. This short course, will define core concepts and main principles of the methodology, share key tools and discuss their use, share experiences and lessons learned, and address important questions about RBM and its implementation.

Who should attend?

This short course is designed for professionals involved with clinical and data operations.

Learning Objectives

At the conclusion of this short course, participants should be able to:
  • Define core concepts and main principles of the TransCelerate risk-based monitoring (RBM) methodology
  • Discuss the use of key tools in the RBM process
  • Identify common challenges with effective monitoring and discuss how they can be addressed through appropriate use of the RBM methodology


Speakers
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 →
CF

Cecilie Freddie Lange

RBM Specialist, Novo Nordisk A/S
avatar for Stuart Shaw

Stuart Shaw

Risk Based Quality Management Project Leader, Boehringer Ingelheim Pharmaceuticals Inc.
Stuart has over 20 years pharmaceutical experience within Biometrics and Data Management. He has contributed to many regulatory submissions and inspections during this time. Stuart has been working on the implementation of Risk Based Monitoring at Boehringer Ingelheim since 2013... Read More →


Sunday June 18, 2017 1:00pm - 4:30pm
S402ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  • format json
  • Featured Topics RBM
  • Credit Type CME, IACET, RN
  • Tags Tutorial