Safety Reporting in RBQM: Bridging Risk Assessment, Monitoring, and Action
Applied Clinical Trials Online Safety monitoring generates substantial signal volume across risk-based quality management tools, but only 30% to 36% of signals correspond to confirmed issues, suggesting the need for better prioritization, signal consolidation, and alignment between detection and proportional action. Safety reporting is a critical aspect of clinical trial quality, directly impacting patient safety […]
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Clinical Operations Burnout Is Undermining Patient Enrollment
Med City News When coordinators are buried in documentation, scheduling, and data reconciliation, patient engagement is the first thing to go. And when engagement drops, retention drops with it. Clinical trials are powered by people: patients who volunteer, and site teams who sustain them. Yet the modern trial increasingly asks both groups to absorb rising […]
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FDA Announces Major Steps to Implement Real-Time Clinical Trials
FDA The U.S. Food and Drug Administration today announced two major steps as part of an initiative to advance the implementation of real-time clinical trials (RTCT). First, the agency unveiled the successful initiation of two proof-of-concept clinical trials that will report endpoints and data signals to the agency in real time. Second, the agency released […]
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Deliberation No. 2026-051 of 19 March 2026 approving a reference methodology relating to the processing of personal data carried out in the context of health research that does not require the collection of the data subject’s consent for participation in the research (MR-003), and repealing Deliberation No. 2018-154
CNIL / Official Journal The French Data Protection Authority (CNIL), Having regard to Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General […]
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