Embracing a Culture of Quality: Establishing and Maintaining Effective CRO Oversight

“Quality oversight is essential to the success of clinical trials, where patient safety, data integrity, and regulatory compliance are paramount. As trial complexity increases, so does the pressure on sponsors and CROs alike to improve efficiency while maintaining quality.”

Webinar sneak peek

Here are 6 top takeaways from this webinar and their timestamps in the downloadable file. Take a few moments to skip around to the sections that are most valuable to you or save the file for later viewing.

1. 06:15: The importance of CRO oversight
   “Oversight helps to ensure that the data collected is accurate, complete, and verifiable. In addition, CRO oversight has the potential to minimize protocol deviations and maximize compliance with regulations, especially as regulatory bodies are placing an increased emphasis on CRO management and quality by design principles.”
2. 13:34: What to expect in ICH GCP E6(R3)
   “E6(R3) speaks about the importance of identifying the data and process that are crucial to trial quality and the risks that could compromise them…there is an emphasis on fit-for-purpose approaches, including proportionality and risk-based approaches, that focus on maintaining the integrity of critical-to-quality factors that are fundamental to the safety of subjects and the reliability of trial results.”
3. 16:10: How to maintain CRO oversight
   “CRO oversight is a continuous process that monitors multiple components of the clinical research program, from vendor selection all the way through to continuous improvement. Choosing the right CRO partner with the right therapeutic, scientific, and clinical trial expertise and with the right infrastructure is a critical first step. Often the chosen CRO will be involved in selecting and contracting with other study vendors, so your oversight of not only your CRO but their vendor oversight processes is integral to regulatory compliance.”
4. 22:19: Integrating quality into every aspect of a clinical trial
   “The key principles of quality by design include proactive planning that identifies critical processes and data that impact patient safety and data integrity. A risk-based approach focuses resources on areas that are most likely to impact patient safety, data reliability, or study outcomes; and implementation of feedback loops enables continuous improvement in real-time by focusing on patient safety and data reliability.”
5. 29:35: Establishing performance metrics
   “Since every clinical trial is unique, metrics should be tailored to the critical objectives and outcomes of your specific study. These metrics can provide quick and convenient insights into CRO performance that can be monitored. Comprehensive evaluations of these metrics will help to drive continuous improvement throughout the duration of the study.”
6. 33:54: Building a culture of quality
   “While processes and technology are key components, building a culture of quality really comes down to people…Organizational leaders must prioritize quality and demonstrate their commitment through action, appropriate resource allocation, and employee engagement.”