Recent Tufts CSDD research shows that the cost of clinical trial delays is much lower than previously thought, underscoring the importance of Risk-Based Quality Management (RBQM) and Quality by Design (QbD). Cyntegrity's Johann Proeve, PhD, and Anastasia Shapovalova, MSc, highlight the benefits of a data-driven approach and live process monitoring in enhancing trial efficiency.
Clinical trials require a comprehensive approach to ensure quality and efficiency. Quality by Design, Risk-Based Monitoring, and Risk-Based Quality Management work together to achieve these goals, focusing on building quality into the trial process, targeting monitoring activities, and continuously improving trial quality.
With the ICH E6(R3) guideline set for approval by October 2024, sponsors face new requirements in risk management, RBQM, and data integrity. Stay compliant and efficient by downloading our free infographic that highlights the key differences between ICH E6(R2) and E6(R3).
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!
Transform your clinical operations into a predictable and compliant process with the MyRBQM® Portal Clinical studies are increasingly integrating a quality-by-design (QbD) methodology, requiring in-depth risk-based quality management (RBQM) software to optimize workflows and data management. With integrated ICH-compliant [...]
In the ever-evolving landscape of clinical trial risk management, effective communication between various systems is crucial for streamlined operations and regulatory compliance. The MyRBQM Portal, a leading risk-based quality management (RBQM) tool, introduces advanced API integration capabilities tailored to clinical operations and risk management [...]
Explore key takeaways from the PHUSE US Connect 2024 conference, highlighting the future of clinical trials, the importance of data integrity, and the role of AI/ML methodologies. Discover how Cyntegrity's vision for QbD and integrated RBQM is shaping the industry.
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!
Be prepared for ICH E6(R3): turn guidelines into real-world action. In this post, we delve into the key updates and training gaps.
Unpacking the new ICH guidelines, E6(R3) and E8(R1), we illuminate their key elements, identify gaps, and compare the two in terms of their unity, differences, and complementarity.
