Clinical Research: How to Use Risk-Based Monitoring and Clinical Corrective Action and Preventative Action (CAPA) to Ensure Compliance

It’s estimated that the average cost of developing a new drug has increased from $1 billion in 2010 to $1.1 billion in 2012. A big part of the cost can be attributed to clinical research, which typically lasts at least eight-and-a-half years.

Given the enormous cost, time, and effort involved in clinical research, sponsors and CROs need to mitigate risks and ensure compliance during this phase to be able to launch their products in a timely manner and avoid unnecessary delays and additional costs.

Regulatory bodies are likewise emphasizing the need to mitigate clinical-trial risks as reflected by guidances and requirements pertaining to risk-based monitoring and quality-by-design (QbD) approach in clinical trials. This is in addition to the requirement that sponsors and CROs integrate CAPA (corrective action and preventative action) as a tool for ensuring patient safety and data integrity throughout the clinical trial.

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 free 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).