WASHINGTON–(BUSINESS WIRE)–#Brexit–The Association of Clinical Research Organizations (ACRO) has released two white papers on risk-based monitoring and risk based quality management, titled Establishing Risk-Based Monitoring within a Quality-Based System as “Best Practice” for Clinical Studies and Risk Based Quality Management (RBQM) – A Collaborative Approach to Holistic Clinical Trial Oversight respectively.
The first white paper outlines the results of a survey completed by ACRO members. Members revealed that risk-based monitoring (RBM) makes the clinical trial quality review process more efficient and effective. The survey found 17 percent of ACRO members using the RBM approach better detect significant deviations in trial data that could potentially indicate a risk to patient safety.
The second white paper highlights the need for greater collaboration and efficiency through a shared vision of risk based quality management (RBQM). ACRO’s cross-company team of subject matter experts found that when sponsors, CROs and vendors can work from a shared, proactive plan, they can then tailor their oversight strategy to support improved quality and safety of clinical trial execution.
In a Morning Consult piece, ACRO’s Executive Director Doug Peddicord said: “I urge the FDA to make a definitive statement in guidance that strongly encourages research sponsors, clinical research organizations and technology companies to fully adopt risk-based quality monitoring so that evidence-based new drugs can get to the patients who need them, sooner.”
ACRO sees the value in supporting industry-wide practices and aims at ensuring greater collaboration and efficiency through a shared vision of risk-based quality management (RBQM). Through collaboration on a shared, proactive plan, the industry can tailor an oversight strategy to support improved quality and safety of clinical trial execution.
About ACRO
The Association of Clinical Research Organizations (ACRO) represents companies that provide a variety of specialized services that 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 employ more than 130,000 professionals worldwide and conduct or support the vast majority of clinical trials.
Contacts
Anina Adelfio, aadelfio@acrohealth.org