Clinical research sites using RealTime's eSource application will gain expanded access to IgniteData's Archer platform.
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 ...
There are two Electronic Data Capture systems managed by the Yale Research Informatics Office – REDCap and Advarra eSource + EDC. Both systems are secure web applications for building and managing ...
IgniteData and RealTime eClinical Solutions have announced a partnership that will allow research sites using RealTime's ...
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US regulators have released a new draft guidance document aimed at providing industry with insight on the use of electronic source data in clinical investigations.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 ...
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Last week, FDA issued the final version of its 2023 revised draft guidance, “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers,” which ...
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 ...
Oracle is introducing significant advancements to its Electronic Data Capture (EDC) solution, Oracle Clinical One Data Collection, offering new capabilities that enable seamless interoperability with ...
US Food and Drug Administration (FDA) officials have finalized a November 2012 draft guidance on the use of electronic source data in clinical investigations, calling for its greater use to promote ...
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 ...