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RBQM

RBQM is laser-focused. Risk-based Quality Management (RBQM) considers each research program holistically, identifies areas of increased risk, and uses that information as the basis for a customized monitoring program. RBQM is not “reduced” monitoring, it is strategic monitoring based on technologically enabled, risk-based algorithms that focus monitoring resources on the locations and activities where they are most needed.

RBQM isn’t static. If risk levels increase at any phase or stage of a study, monitoring can quickly be intensified.

The power of RBQM lies in risk identification and strategic vigilance.

Feb 2025

Site Readiness Under ICH E6(R3): Key Guidance for Sponsors

By |2025-02-26T22:37:15+02:00February 26, 2025|Blog, Free Infographics, News, Resources|Comments Off on 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. This concise article outlines critical updates, from risk-based monitoring to formalized documentation, ensuring your clinical trial operations align with leading edge GCP requirements and maintain the highest standards of patient safety and data integrity.

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Jan 2025

Why EDC Needs RBQM for Smarter Clinical Trial Management

By |2025-01-15T10:04:42+02:00January 14, 2025|Blog, News|Comments Off on 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.

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Dec 2024

Streamlining Clinical Trials: FDA Guidance Meets RBQM Strategy

By |2025-01-17T12:35:24+02:00December 31, 2024|Good Clinical Practice, News|Comments Off on 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The recently launched FDA’s draft guidance on protocol deviations highlights the importance of compliance and risk management.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.

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Dec 2024

ACDM Features RBQM Shift from ClinOps to Data Science

By |2024-12-31T10:31:39+02:00December 30, 2024|News|Comments Off on 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.

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Nov 2024

Why Sponsors Should Embed RBQM Principles and Adaptive Monitoring Strategies in Protocol Design

By |2025-01-17T12:39:35+02:00November 19, 2024|Blog, Good Clinical Practice, News|Comments Off on 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.

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Aug 2024

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

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

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.

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May 2023

Training Implications of the ICH E6(R3) and E8(R1) Guidelines

By |2024-09-11T16:49:40+02:00May 29, 2023|Blog, Good Clinical Practice, News|0 Comments

Be prepared for ICH E6(R3): turn guidelines into real-world action. In this post, we delve into the key updates and training gaps.

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May 2023

Embracing the Future: FDA’s New Draft Guidance on Decentralized Clinical Trials

By |2023-05-12T17:33:36+02:00May 12, 2023|Blog, News|Comments Off on Embracing the Future: FDA’s New Draft Guidance on Decentralized Clinical Trials

Dive into the FDA's latest draft guidance on Decentralized Clinical Trials and the role of Risk-Based Quality Management. Learn how RBQM and centralized monitoring can elevate your clinical research efficiency and reliability.

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Mar 2023

Synergy of QbD, RBM, and RBQM in Trials

By |2024-06-14T17:44:33+02:00March 20, 2023|Blog, News|Comments Off on 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.

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Mar 2023

What’s the Difference Between RBQM and QRM in Clinical Trials?

By |2024-06-14T18:09:56+02:00March 6, 2023|Blog, News|Comments Off on What’s the Difference Between RBQM and QRM in Clinical Trials?

In clinical trials, managing risks that could impact data quality is crucial for ensuring patient safety, data integrity, and regulatory compliance. While Risk-Based Quality Management (RBQM) and Quality Risk Management (QRM) are both approaches designed to manage risks, the two have essential differences.

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