How to Use Risk-Based Monitoring and Clinical CAPA to Ensure Compliance

This white paper will discuss the importance of risk-based monitoring and CAPA in clinical research within the context of the following initiatives by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA):
  • 2013 Guidance
  • Clinical Trial Transformation Initiative (CTTI)
  • EMA's Reflection Paper on Risk-Based Quality Management in Clinical Trials


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