How To Use Risk- Based Monitoring And Clinical CAPA To Ensure Compliance

By James Jardine

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.

Most sponsors and CROS already have risk-based monitoring and clinical CAPA processes, or at least they are familiar with the concept. But their existing processes are not as effective and efficient. If your organization happens to be in this situation, take advantage of the latest CQMS technology that would allow you to have both processes integrated into your quality management system. A robust CQMS will help you mitigate risks, maintain high quality data and information across your trial sites, and ensure compliance throughout the life of your clinical research.

A robust clinical quality management system (CQMS) can help you mitigate risks, maintain high quality data and information across your trial sites, and ensure compliance throughout the life of your clinical research.