A Web-based point-and-click EDC known as Brocade was internally developed and implemented systemwide in 2016. Brocade captures key data elements, such as stage, histology, and patient and treatment ...

ClinCapture announces AI-powered clinical trial build tech that automates study configuration, and advances intelligent architecture for clinical research. We believe the future of clinical research ...

Last week, FDA issued the final version of its 2023 revised draft guidance, “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers,” which ...

US regulators have released a new draft guidance document aimed at providing industry with insight on the use of electronic source data in clinical investigations. The guidance, set to be published on ...

The U.S. Food and Drug Administration is seeking to conduct demonstration projects testing the capability and performance of a single-point data capture approach between EHRs and electronic data ...