Last week, the U.S. Food and Drug Administration (FDA) published a draft guidance on the use of data monitoring committees (DMCs) in clinical trials entitled “Use of Data Monitoring Committees in ...

Clinical trial monitoring and quality assurance are pivotal elements in the successful conduct of clinical research. These processes ensure that trials adhere to regulatory requirements, maintain high ...

On February 13, 2024, the US Food and Drug Administration (FDA) issued draft guidance entitled Use of Data Monitoring Committees in Clinical Trials (Draft Guidance). It provides sponsors and others ...

WASHINGTON--(BUSINESS WIRE)--Today, ACRO’s RBQM Working Group has announced the publication of its latest RBM/RBQM paper, Risk-Based Quality Management: A Case for Centralized Monitoring, in DIA’s ...

Wells 1 focuses our attention on confidentiality of preliminary data in ongoing clinical trials. Based on his views of circumstance, regulation, and ethics, he concludes “… the medical and scientific ...

Beccy holds a PhD in Biological Science, a Master’s in Molecular Biology of Parasites and Disease Vectors, and a Bachelor’s in Human Biology and Forensic Science. Beccy holds a PhD in Biological ...

Among the many catchphrases of the Affordable Care Act individual mandates, pre-existing conditions clinical trials is one that has flown under the radar. But in terms of immediate impact, it is one ...