Search results for: QbD

The Real Cost of Delays in Drug Development and the Role of RBQM and QbD

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.

By |2024-08-08T10:52:32+02:00August 8, 2024|Blog, News|Comments Off on The Real Cost of Delays in Drug Development and the Role of RBQM and QbD

Synergy of QbD, RBM, and RBQM in Trials

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.

By |2024-06-14T17:44:33+02:00March 20, 2023|Blog, News|Comments Off on Synergy of QbD, RBM, and RBQM in Trials

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.

By |2024-10-31T10:30:22+02:00October 30, 2024|AI in Clinical Trials, Blog, Good Clinical Practice, News|Comments Off on Navigating ICH E6(R3): New Standards for Medical Monitoring

AI-Enhanced Subject Profiles: Simplifying Medical Monitoring

AI-Enhanced Subject Profiles Elevating Medical Monitoring in Clinical Trials Unified Subject Data Access All critical patient insights in one place AI-Powered Data Quality & Risk Detection Proactively identify data anomalies and risks Customizable Monitoring Flexibility [...]

By |2024-11-27T15:58:50+02:00October 29, 2024|Comments Off on AI-Enhanced Subject Profiles: Simplifying Medical Monitoring

Preparing for the Transition to ICH E6 R3 – Key Sponsor Responsibilities

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).

By |2024-11-25T19:43:54+02:00September 11, 2024|Free Infographics, Good Clinical Practice, News|Comments Off on Preparing for the Transition to ICH E6 R3 – Key Sponsor Responsibilities

MyRBQM Portal 2024

MyRBQM® Portal: Quality by Design in Action 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 workflows, the MyRBQM Portal facilitates a quality-by-design [...]

By |2024-11-20T13:26:37+02:00April 4, 2024|Comments Off on MyRBQM Portal 2024

Enhancing Clinical Trial Efficiency with API Integration in the MyRBQM Portal

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 [...]

By |2024-03-12T21:17:05+02:00March 7, 2024|Blog, Neat Features, News, Product Updates, RBQM Product Updates|Comments Off on Enhancing Clinical Trial Efficiency with API Integration in the MyRBQM Portal

Key Takeaways from PHUSE US Connect 2024

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.

By |2024-05-10T17:03:25+02:00March 5, 2024|AI in Clinical Trials, Blog, News|Comments Off on Key Takeaways from PHUSE US Connect 2024

Decoding the ICH’s Q9(R1) Quality Risk Management Guideline

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!

By |2024-11-25T17:26:20+02:00December 4, 2023|Blog, Free Infographics, Good Clinical Practice, News|Comments Off on Decoding the ICH’s Q9(R1) Quality Risk Management Guideline
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