Health tech company Flatiron Health, an independent affiliate of the Roche Group, is expanding the reach of its clinical data capture tool through a pact with NRG Oncology. NRG Oncology is a 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Last week, FDA issued the final version of its 2023 revised draft guidance, “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers,” which ...
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 ...
US regulators have released a new draft guidance document aimed at providing industry with insight on the use of electronic source data in clinical investigations.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 ...
In the last decade, the volume of clinical trial data has surged, presenting unprecedented challenges for sponsors and contract research organizations (CROs). The task of collecting, cleaning, ...
Although the potential transformative effect of electronic health record (EHR) data on clinical research in adult patient populations has been very extensively discussed, the effect on pediatric ...
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