ACRO Releases New Report on the Past, Present, and Future of Risk-Based Monitoring

Risk-based monitoring (RBM) is a powerful tool for efficiently ensuring patient safety and data integrity in a clinical trial, enhancing overall trial quality. To better understand implementation across the industry, the Association of Clinical Research Organizations (ACRO) conducted a landscape survey of RBM implementation across 6,513 clinical trials that were ongoing in 2019 and compiled the information in a comprehensive report.

After an unprecedented year, the clinical research industry has proved innovative, even in difficult circumstances. ACRO’s latest report highlights a significant shift to risk-based monitoring, titled “Risk-based Monitoring in Clinical Trials: Past, Present & Future.” It also supports the industry shift towards a more holistic Risk Based Quality Management (RBQM) system.

“The COVID-19 crisis emphasized the pivotal role that Risk Based Quality Management (RBQM) plays in clinical trial development,” said Brian Barnes, Director of Product Development at Medidata, a Dassault Systèmes company, and co-lead of ACRO’s RBQM Working Group. “RBQM focuses monitoring on trial processes most likely to affect patient safety and data quality so that sponsors, CROs, and investigators can quickly and effectively mitigate risks or address errors before they affect trial quality.”

This new report builds on the progress of ACRO’s RBQM working group, which released two white papers in 2019:

1. Risk Based Quality Management (RBQM) – A Collaborative Approach to Holistic Clinical Trial Oversight
2. Establishing Risk-Based Monitoring within a Quality-Based System as “Best Practice” for Clinical Studies

“This report is a great example of how ACRO is engaging with industry stakeholders including regulators and biopharma to enhance approaches in clinical trials,” said Steve Cutler, CEO of ICON plc and ACRO 2021 Board Chair. “We look forward to future engagements with regulators, stakeholders, and customers to continue promoting RBQM as a best practice for the clinical research industry.”

About ACRO

The Association of Clinical Research Organizations (ACRO) represents clinical research and technology companies that provide a variety of specialized services to support the development of new pharmaceuticals, biologics, and medical devices. Through its member companies, ACRO helps improve the quality, efficiency, and safety of biomedical research. ACRO member companies operate in more than 100 countries across the globe and conduct or support the conduct of the majority of clinical trials worldwide.

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