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Janus clinical trial data repository is a clinical trial data repository (or data warehouse) standard as sanctioned by the U.S. Food and Drug Administration (FDA). It was named for the Roman god Janus (mythology), who had two faces, one that could see in the past and one that could see in the future.
A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ various means to verify the data. Systems for ...
HIVE Logo. The High-performance Integrated Virtual Environment (HIVE) is a distributed computing environment used for healthcare-IT and biological research, including analysis of Next Generation Sequencing (NGS) data, preclinical, clinical and post market data, adverse events, metagenomic data, etc. [1] Currently it is supported and continuously developed by US Food and Drug Administration ...
Often, a clinical trial management system provides data to a business intelligence system, which acts as a digital dashboard for trial managers. [5] [6] [7] CTMSs allow experts easily to access centralized data and thus reducing the number of delayed trials. Sponsors can work with a database of previously researched contacts and names of ...
Medidata Solutions is an American technology company that develops and markets software as a service (SaaS) for clinical trials.These include protocol development, clinical site collaboration and management; randomization and trial supply management; capturing patient data through web forms, mobile health (mHealth) devices, laboratory reports, and imaging systems; quality monitor management ...
The FDA will require companies to file plans on how they intend to increase diversity in studies of most new drugs and medical devices under the 2022 Food and Drug Omnibus Reform Act.
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