Explore the ICH E6(R3) Interactive Visualizer
Explore how ICH E6(R3) reshapes GCP. The free, eyesON Interactive Visualizer transforms regulatory history into a clear, data-driven journey toward quality-by-design clinical trials.
CASE STUDY | Phase III Oncology: Targeted Risk-Based QA
For oncology study teams: see how ADAMAS applied Cyntegrity’s risk signals to focus QA in a global Phase III trial, supporting earlier actions and inspection readiness.
MHRA 2025: New Guidance for Medical Device Investigations
The MHRA’s latest guidance clarifies how medical device investigations are managed across Great Britain and Northern Ireland. Cyntegrity helps manufacturers stay inspection-ready with AI-enhanced RBQM tools that strengthen documentation, risk control, and overall data quality from design through post-market follow-up.
World Heart Day 2025: Smarter Heart Trials
On World Heart Day 2025, Cyntegrity highlights the importance of safer, smarter cardiovascular clinical trials. Using the Heart Failure RACT and Risk-Based Quality Management, we help identify patient risks early, improve trial design, and ensure data quality keeping patient safety at the heart of every study.
Clinical Trials and Patient Safety
Every 17 September, World Patient Safety Day reminds our industry that safety is not just an outcome, it’s a discipline. In clinical research, safety begins long before first-patient-in and continues with every data point captured, every deviation resolved, and every monitoring decision made.
FDA Finalizes ICH E6(R3) Guidance, But U.S. Timeline Still Unclear
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.
DIA 2025 Posters: Rare-Disease & CRF-RBQM Wins
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
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.
Site Readiness Under ICH E6(R3): Key Guidance for Sponsors
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: Microsoft-Certified AI in Healthcare
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.
Adopting ICH E6(R3): What Sponsors, CROs, Sites, and Participants Need to Know
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.
Why EDC Needs RBQM for Smarter Clinical Trial Management
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.