Currently Browsing: RBM

COVID-19Lessons Learned

Technology solutions: Weathering a storm, helping envision a future

November 16, 2020

We all had a flurry of unprecedented activity. We were assessing risks to patients and data, and putting in place mitigation strategies to preserve continuity of the studies.” Those strategies involved thousands of amendments to protocols, adapting to sudden changes that impacted patients and sites around the world.

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New ACRO Report Quantifies Benefits of RBM for Quality Reviews

October 17, 2019

A new report based on a survey of ACRO members reveals that Risk-Based Monitoring (RBM) makes clinical trial quality review more efficient…

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Advancing the Adoption of Risk-Based Monitoring Strategies in Clinical Trials

August 16, 2019

On July 17, 2019, under cooperative agreement with the FDA, the Duke-Margolis Center for Health Policy (Duke Margolis) held a public workshop. The event, titled Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations, aimed to identify opportunities to improve Risk Based Monitoring (RBM) implementation and solicit stakeholder input on the challenges, barriers, and enablers that impact the successful adoption of RBM.

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NewsPress Releases

ACRO offers unique insights on risk-based monitoring of clinical trials, calls for adoption of RBM as a best practice

May 16, 2019

Following meetings with then-Commissioner Scott Gottlieb and senior leadership from the Center for Drug Evaluation and Research on the role of CROs and technology companies in designing and implementing risk-based monitoring (RBM) of clinical trials, ACRO this week submitted extensive comments on recent FDA Guidance.Increasing the use of innovative RBM technologies helps make clinical trials safer, more efficient and higher quality. ACRO’s comments offer unique insights into the recent expansion of RBM implementation and call for further increasing the use of these oversight technologies.