The U.S. FDA’s draft guidance for reporting of deviations from clinical study protocols lends some insight as to the definition of a deviation, but the agency highlights some concerns about related ...

BURLINGTON, Mass., May 22, 2025 /PRNewswire/ -- Clymb Clinical is proud to announce the launch of TFL Viewer, a state-of-the-art SaaS application designed to streamline the review, feedback, and ...

A protocol deviation or violation is any departure from the study procedures or treatment plans as specified in the IRB-approved protocol. Protocol deviations occur when an investigator does not ...

BioVie has blamed "protocol deviations" at a number of clinical trial sites for the failure of a potential Alzheimer’s disease drug while claiming that the evaluable data still shows the candidate ...

WCG has introduced Total Training, a clinical trial solution designed to reduce protocol deviations and enhance site readiness, engagement, and compliance. This new offering integrates various ...

The investigation focuses on the propriety of BioVie’s disclosures concerning its adherence to Good Clinical Practice (“GCP”) and protocols related to its Phase 3 clinical trial of NE3107, a potential ...

However, clinical trials in all therapeutic areas, and particularly in oncology, are increasing in complexity, leading to challenges in achieving timely and full enrollment, protocol deviations, and ...