Explore the impact of ICH's Q9(R1), Quality Risk Management, guideline on RBQM and clinical trials in our latest blog post. Don't miss our free infographic that simplifies this complex guideline. Enhance your risk strategies today!
Don’t Miss Out! We’re excited to announce that our CEO, Artem Andrianov, will be hosting an exclusive workshop at the 10th Annual Clinical Monitoring and Patient Recruitment Retention (CMPRR) Summit in Barcelona this November!
Building Critical to Quality Trees helps you to translate critical study needs and quality drivers into measurable outcomes and processes. Initially, this Lean Six Sigma approach serves as a business tool based on customer needs. Still, it is a helpful method of implementing Quality by Design in clinical research.
Join Cyntegrity at SCOPE 2025 Barcelona, Booth #4, and explore how AI-powered RBQM cuts review cycles by 30% and boosts inspection readiness.
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.
Join Cyntegrity & Microsoft in Frankfurt for a leadership roundtable on AI & QbD with guest speaker Andrew Warrington, (Senior Industry Advisor.)
Efficient Clinical Data Management Accelerating Data Oversight in Clinical Trials Unified Data Access All critical information in a single, centralized view—combining EDC, lab, and external data sources Proactive Data Quality & Risk Detection Pinpoint discrepancies early and move forward with fewer [...]
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The recently launched FDA’s draft guidance on protocol deviations highlights the importance of compliance and risk management.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.
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.
