A big part of the cost of developing a new drug can be attributed to clinical research, which typically lasts at least eight-and-a-half years. For this reason, regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are emphasizing the need to mitigate clinical-trial risks (1).

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.

While most companies have risk management and clinical CAPA processes, they’re not leveraging CAPA to strengthen risk management and vice versa. If your company is a sponsor or a CRO, how effective are your risk management and clinical CAPA processes? Are you using them to supplement each other?

RISK BASED MONITORING VIS A VIS CLINICAL CAPA
If your organization already has risk management and clinical CAPA processes, consider the following strategies for leveraging those processes:

• Use QbD Principles:  When you apply quality-by-design (QbD) principles, your goal is to minimize, if not prevent, deviations by incorporating risk management, CAPA, and other GCP principles in your clinical research. QbD calls for careful examination of the study’s key processes, which will help identify risks. These risks can be addressed early on by tailoring the clinical trial design.
• Use the PDCA Approach:  The Plan-Do-Check-Act approach, also known as the Deming Cycle, provides a continuous loop of feedback, which is essential to continuous improvement.
• Ensure that the TMF is Complete:  Regulatory bodies evaluate the conduct of a clinical trial by reviewing and/or inspecting essential documents that constitute the Trial Master File (TMF). Generating essential documents is very important, but maintaining quality (e.g., accuracy of files) is equally critical.
• Leverage the Flexibility of Monitoring Visit Reports:  If your company is using an electronic clinical quality management system (CQMS) with a “monitoring visit reports” tool, leverage it in your risk management process. The FDA now encourages a more modern and flexible risk-based approach in monitoring clinical trials, including wider use of alternative approaches and electronic tools.
• Integrate Training with CAPA to Boost Risk Management:  Most CAPAs require re-training and in that case, both CAPA and training become critical to risk management. Your CQMS should connect CAPA, training, risk management, and all other critical clinical processes.
• Establish CAPA and Risk Management as Part of CQMS:  If your organization is still using paper-based or hybrid processes, you should take advantage of the latest technology and switch to an electronic CQMS that will serve as the centerpiece of your compliance efforts. Choose a solution that provides CAPA and risk management tools that are complementary so they all serve to strengthen your processes.

CONCLUSION
Most sponsors and CROS already have risk-based monitoring and clinical CAPA processes, or at least they’re 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.

This article is based on a white paper (“How to Use Risk-Based Monitoring and Clinical CAPA to Ensure Compliance”) offered by MasterControl. If you’re interested in reading the white paper, you may download it below for free.

REFERENCE

The FDA’s “2013 Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring” and the EMA’s “Reflection Paper on

Risk-Based Quality Management in Clinical Trials” highlight the importance of a risk-based approach in clinical trials.

Note: This article is used with permission from GxP Lifeline and has been previously published at www.mastercontrol.com.”

Bio:

Cindy Fazzi, a copywriter at MasterControl Inc., writes about the life science industry and other regulated environments. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York. She has a master’s degree in journalism from Ohio State University.