ACRO Publishes Newest Landscape Survey Results: Risk-Based Quality Management in Clinical Trials

January 25, 2023 By 0 Comments

WASHINGTON, DC – This week, the Association of Clinical Research Organizations (ACRO)’s RBQM Working Group published a paper in DIA’s Therapeutic Innovation & Regulatory Science journal titled, Risk-Based Monitoring in Clinical Trials: 2021 Update.

For the past three years, ACRO’s RBQM Working Group has conducted an annual landscape survey of member company CROs to determine how remote monitoring and risk-based quality management processes are being implemented across the industry. The group looked at adoption rates of remote monitoring, quality tolerance limits (QTLs), centralized monitoring, and several other components. This paper details the latest findings, drawing on collected data on 5,000+ ongoing clinical trials for each of the past three years.

ACRO’s first survey project started the year prior to the COVID-19 pandemic. As a result, the subsequent two years provide a unique perspective on how adoption rates of remote- and risk-based approaches have changed and evolved through the pandemic, and over time.

“The ACRO team worked together to gather this data for a third consecutive year, and we believe it’s telling in how clinical trials are currently being operationalized and will be run in the years to come,” said the RBQM Working Group’s lead, Brian Barnes, RBQM Strategy Specialist at Medidata Solutions.

With the continued impact of the pandemic on how clinical trials are designed and executed and the increasing number of partially or fully decentralized clinical trials (DCTs), ACRO’s RBQM Working Group expects these adoption rates to continue to increase over time.

By sharing this data, the CROs and technology providers of ACRO hope to continue collaborating across all stakeholders, from ACRO members, to sponsors and regulators to make collective progress towards advancing how clinical trials are conducted most effectively and efficiently.

The 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

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 industry-sponsored clinical trials worldwide.