Successfully navigating the evolution of Good Clinical Practice requires well-defined implementation Strategies for ICH E6(R3). With the release of the new draft in May 2023 for public consultation, significant changes have been introduced compared to the ICH E6(R2) guideline published in 2016. These updates span three key areas – data governance, computer system validation (CSV), and oversight activities – all intricately interwoven with the principles of Risk-Based Quality Management (RBQM). Beyond simply codifying existing best practices, R3 strongly suggests that sponsors adopt a proportionate approach to identifying and managing areas of risk, which involves setting acceptable ranges for each identified risk and actively evaluating deviations from those thresholds to identify negative trends proactively. The ultimate aim of these changes and strategies is to guide companies in anticipating and addressing potential problem areas, thereby significantly improving overall clinical trial quality.
It is absolutely critical to acknowledge that effective implementation of ICH E6(R3) will be different for every single organization and every unique clinical trial. Seeking generic answers or one-size-fits-all solutions from partners or even regulators about what constitutes “critical to quality” fundamentally misses the core concept of RBQM, which is inherently protocol-specific. Organizations must shift their focus inward, diligently thinking about the specific elements most important to protecting patients and preserving trial data integrity within the context of their specific project and development program. This tailored approach is essential for true compliance and quality improvement under the new guidelines.
This is precisely where inSeption Group provides essential expertise and support. At inSeption Group, we specialize in helping sponsors develop and execute effective, tailored Strategies for ICH E6(R3) implementation. We understand that generic approaches won’t suffice. Our team partners with you to navigate the nuances of the new guidelines, assisting in adopting the proportionate risk approach, identifying critical quality elements specific to your protocols, and developing practical strategies for data governance, CSV, and oversight. We help translate the E6(R3) principles into actionable processes that integrate seamlessly with your existing QMS and operations, ensuring compliant, efficient, and high-quality clinical trials in this evolving regulatory landscape.
To learn more about how inSeption Group helps develop and implement effective Strategies for ICH E6(R3), read the full article.
