ACRO’s Artificial Intelligence/Machine Learning Committee produced the following Principles Statement in December 2023. The committee represents the industry to regulators and policymakers considering regulation and legislation that could impact the use of AI/ML in drug development.
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Risk based monitoring is an adaptive approach that directs monitoring focus and activities to the evolving areas of greatest need which have the most potential to impact patient safety and data quality. How much do you know about Risk-Based Monitoring (RBM)? This webinar series from ACRO’s CRO Forum and The Society for Clinical Research Sites (SCRS) aims to educate
How much do you know about Risk-Based Monitoring (RBM) Read More »
ACRO DCT White Paper: A New Quality-by-Design, Risk-Based Framework ACRO’s DCT White Paper provides an overview of considerations for decentralized clinical trials and introduces the Quality-by-Design Manual and Risk-Assessment Template.
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Cassandra Strickland Kennedy has served as Chief Quality, Regulatory Affairs, and Sustainability Officer since May 2023 with oversight of Global Regulatory Compliance, Quality Assurance and Environmental, Social and Governance at Fortrea. Sandy brings more than three decades of biopharmaceutical industry experience, with a long track record of success in leadership positions within the pharmaceutical and
ACRO’s RBQM report shows how clinical trials were forced to shift to remote monitoring during the COVID-19 pandemic, and highlights why the industry shouldn’t turn back. 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 the RBM implementation
Risk-based Monitoring in Clinical Trials: Past, Present & Future Read More »
ACRO’s 2021 RBQM Summary Report highlights the key takeaways from ACRO’s RBQM survey, outlining the current state of RBM & RBQM in the clinical research industry. You can find full results and in-depth discussion in ACRO’s January 2023 publication, Risk-Based Monitoring in Clinical Trials: 2021 Update.
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WASHINGTON, DC – Washington DC – ACRO today announced that its Board of Directors has elected Peyton Howell, Chief Operating & Growth Officer at Parexel, as Chair of the association effective Jan. 1, 2024. Lisa Moneymaker, Chief Technology Officer & Chief Product Officer at Saama, was elected Vice Chair. In addition, the Board of Directors
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As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to European Data Protection Board in 2020 about ACRO joins with EFPIA and the IPMPC in comment to European Data Protection Board can be found below.
ACRO joins with EFPIA and the IPMPC in comment to European Data Protection Board Read More »
As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to European Commission in 2021 about ACRO Policy Recommendations for Guidance on Electronic Systems and Electronic Data in Clinical Trials can be found below.
