Get it right, make it safe. See how AI-augmented RBQM and Quality by Design work together to cut avoidable burden and safeguard patients, from Protocol Complexity Analysis at design to AI-enhanced Subject Profiles in medical monitoring.
The FDA has published the finalized ICH E6(R3) Good Clinical Practice guidance. Unlike Europe’s July 23 deadline, the U.S. implementation date is still to be announced. This creates uncertainty for sponsors and CROs operating across regions, highlighting the importance of early preparation and alignment with global standards.
Download our DIA 2025 posters and see how upfront RBQM—applied to rare-disease trials and joint CRF design—sharpens data quality, elevates patient safety, and keeps studies ICH E6(R3)-ready.
EMA's new Clinical Trials Map transforms overwhelming trial data into actionable geographic insights. Anastasia, Cyntegrity's Head of Centralized Monitoring, explains why this intuitive map is essential for smarter, data-driven recruitment strategies.
Discover how the finalized ICH E6(R3) guideline elevates site and sponsor collaboration, emphasizing robust training, resource allocation, and digitally empowered data governance.
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.
