How to Use Risk-Based Monitoring and Clinical CAPA to Ensure Compliance
If your company is a sponsor or a CRO that conducts clinical research for a sponsor, how effective are your risk management and clinical CAPA processes? Are you using a risk-based approach to monitoring and CAPA to mitigate the risks during clinical research and 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
