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CBI’s Risk-Based Approaches to Clinical Investigations

Data Quality, Operational and Technological Considerations

April 10-11, 2012
  • Philadelphia, PA

Available for $298.00

Is your organization prepared to move towards a risk-based approach to clinical investigations?

The FDA recently issued draft guidance on the “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring.”  The EMA also issued a reflection paper on “Risk-Based Quality Management in Clinical Trials.”  Recommendations in these guidance’s include the adoption of more risk-based methods by sponsors – moving from onsite evaluations of study sites to remote/centralized monitoring.  Utilizing this approach changes the way sponsors conduct clinical trials.  New SOPs need to be written.  Statisticians must be involved to develop a trial-by-trial risk-based strategy.  Technology such as EDC becomes even more crucial to the success of a clinical trial.  This approach affects people, process and technology as well as the quality and integrity of clinical data.     

This conference provides site management, clinical monitoring, data management, quality management and statistics professionals the opportunity to discuss the movement towards a risk-based approach to clinical trials.  The recent FDA and EMA draft guidance on clinical oversight are discussed as well as operational, data management, regulatory and technological challenges of this approach.

Topics to be addressed include:

  • Overview of the FDA and EMA draft guidance
  • Appropriate balance of on-site vs. centralized monitoring
  • Organizational changes required to implement the new risk-based model
  • Statistical tools that enable the design of risk-based plans
  • Threshold triggers to identify predictable risks
  • Data management and quality considerations