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 ...
Last week, FDA issued the final version of its 2023 revised draft guidance, “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers,” which ...
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 ...
New eTMF module integrates with Enlighten Clinical Solutions’ platform to support inspection-ready clinical trial ...
On October 1, 2024, the US Food and Drug Administration (FDA) finalized its guidance on the use of electronic records in clinical investigations of drugs, devices, biologics, foods, tobacco products ...
MORRISVILLE, N.C., Feb. 08, 2023 (GLOBE NEWSWIRE) -- Syneos Health® (Nasdaq:SYNH), the only fully integrated biopharmaceutical solutions organization, today announced a strategic partnership with ...
UC San Francisco (UCSF), in collaboration with the Quantum Leap Healthcare Collaborative (QLHC) and the U.S. Food and Drug Administration (FDA) has developed the OneSource system to seamlessly ...
BOSTON--(BUSINESS WIRE)--YonaLink, a clinical trial software provider, today announced that is has completed an initial funding round, raising $6 million, to scale global growth and expand its ...
A recent influx of digital technology has unlocked tremendous potential for clinical trials. For an industry that has traditionally relied on patients’ paper intake forms and manual data entry into ...
Electronic clinical trials are moving from standalone, point solutions toward software suites, similar to the way office applications migrated in the 1980s. Eventually, investigators will have a ...
Electronic Data Capture (EDC) Providers and System Use EDC is the most widely adopted clinical application, used by all respondents (100%), followed by randomization and trial supply management (77%), ...
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