Discover how the finalized ICH E6(R3) guideline elevates site and sponsor collaboration, emphasizing robust training, resource allocation, and digitally empowered data governance. This concise article outlines critical updates, from risk-based monitoring to formalized documentation, ensuring your clinical trial operations align with leading edge GCP requirements and maintain the highest standards of patient safety and data integrity.
Cyntegrity’s MyRBQM Portal is the first clinical trial data science software to achieve Microsoft Healthcare AI Certification following a rigorous independent audit. This recognition underscores our commitment to ethical, reliable AI solutions and patient safety. Learn more about this milestone and our AI-driven advancements in clinical trials: Read the full article.
The ICH E6(R3) guideline was formally adopted on January 6, 2025, introducing reinforced principles for clinical trial conduct. This final version builds on its draft with clarified expectations and some notable revisions. Let’s explore the highlights and the implications for stakeholders.
With ICH E6(R3) reinforcing proactive quality management, relying on EDC systems with hundreds of edit checks is impractical. The MyRBQM Portal bridges the gap with predictive analytics, historical data views, and real-time risk drill-downs, enhancing oversight and reducing complexity. Learn how EDC and RBQM work together for more insightful, compliant trial management.
The ICH E6(R3) guideline redefines expectations for clinical trial sites, emphasizing proactive planning, data accuracy, and risk monitoring to enhance participant safety and trial efficiency. Download our presentation for practical insights and strategies to ensure compliance and strengthen collaboration.
The recently launched FDA’s draft guidance on protocol deviations highlights the importance of compliance and risk management. Combined with RBQM principles, sponsors can streamline trials, enhance safety, and align with regulations.
Speaking at the 2nd Annual ACDM Symposium on RBQM, our CEO highlighted how RBQM has evolved from supporting Clinical Operations to becoming an integrated approach to data management.
Clinical trial participants have the right to access their personal data, a principle emphasized in the ICH E6(R3) guidelines. Sponsors must ensure transparency and provide participants with their data in a clear and accessible format. Our Subject Profiles tool offers a streamlined solution, enabling sponsors to generate comprehensive reports efficiently, thereby meeting regulatory requirements and enhancing participant trust.
This article explains why sponsors should adopt RBQM principles early in trial planning, supported by regulatory recommendations, and highlights the benefits of early implementation compared to addressing these elements later in the monitoring plan—or not at all.
Preparing for ICH E6(R3)? Discover how medical monitors can adapt to new safety, compliance, and data integrity standards with advanced monitoring tools.
