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.
Maximizing Site Readiness for ICH E6(R3)
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.
Streamlining Clinical Trials: FDA Guidance Meets RBQM Strategy
The recently launched FDA’s draft guidance on protocol deviations highlights the importance of compliance and risk management.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.
ACDM Features RBQM Shift from ClinOps to Data Science
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.
Empowering Trial Participants: The Right to Access Data and How Sponsors Can Deliver with Ease
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.
Why Sponsors Should Embed RBQM Principles and Adaptive Monitoring Strategies in Protocol Design
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.
Navigating ICH E6(R3): New Standards for Medical Monitoring
Preparing for ICH E6(R3)? Discover how medical monitors can adapt to new safety, compliance, and data integrity standards with advanced monitoring tools.