Today, ACRO’s RBQM Working Group has announced the publication of its latest RBM/RBQM paper, Risk-Based Quality Management: A Case for Centralized Monitoring, in DIA’s Therapeutic Innovation & Regulatory Science journal.

In this new publication, ACRO’s RBQM Working Group provides a real-life example of centralized monitoring implementation using a clinical trial from clinicaltrials.gov.

“Centralized monitoring provides a holistic view of aggregate clinical trial data and earlier identification of emergent issues, enabling organizations to make data-driven decisions more quickly,” said Cris McDavid, Director, Risk-Based Quality Management, Parexel, and a member of ACRO’s RBQM Working Group.

By providing a tangible example of centralized monitoring implementation, the paper showcases the benefits of utilizing a risk-based approach to clinical trial monitoring, significantly reducing the need for 100% SDR/SDV.

The paper also highlights trends and takeaways on industry RBM/RBQM adoption from ACRO’s latest RBM/RBQM landscape survey. ACRO’s RBQM Working Group has worked in collaboration with the FDA to track the adoption of risk-based approaches in clinical trials over the past four years.

“In light of our repeated conversations with the FDA, we are pleased to have taken a data driven approach to understanding and characterizing the adoption of RBQM in clinical trials,” said Doug Peddicord, Executive Director, ACRO. “We look forward to further collaboration with all stakeholders to make collective progress towards advancing the safe, efficient and effective conduct of clinical trials.”

This paper and other resources from ACRO’s RBQM Working Group can be found on the ACRO website: https://www.acrohealth.org/risk-based-quality-management/

About ACRO

Founded in 2002, ACRO represents the world’s leading clinical research and technology organizations, which provide specialized services that are integral to the development of drugs, biologics and medical devices. ACRO and its members advocate on a global basis for safe, ethical, high-quality medical research so patients can benefit from the development of new treatments and therapies. Our members are dedicated to helping their clients bring efficiency, innovation and value to the clinical research process.

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