Removing the Risk in Risk-Based Monitoring – A Practical and Proven Approach to Implementing Central Statistical Monitoring
Recorded on June 10, 2013

Hosted by Marc Buyse, Sc.D, Founder, CluePoints and Brian Nugent, Associate Director, Clinical Operations, Gilead Sciences, Inc.

This session provides an in-depth examination of Central Statistical Monitoring (CSM) with an emphasis on the following issues;

  • Statistical principles underlying Central Statistical Monitoring
  • On-site monitoring V.S key risk indicators V.S CSM
  • Operational challenges in implementing CSM
  • Case studies identifying the impact and utility of this unique approach
  • The added value of CSM:
     1.  Improving data quality and integrity
        2.  Reducing regulatory submission risk
        3.  Driving down costs on On-site Monitoring and SDV
        4.  Adhering to the regulatory guidelines and driving
    a RBM strategy












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