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A Clinical Trial Management System ( CTMS) is a software system used by biotechnology and pharmaceutical industries to manage clinical trials in clinical research. The system maintains and manages planning, performing and reporting functions, along with participant contact information, tracking deadlines and milestones.
Electronic data capture. An electronic data capture ( EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. [1] EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and ...
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 ...
IQVIA, formerly Quintiles and IMS Health, Inc., [6] is an American Fortune 500 and S&P 500 multinational company serving the combined industries of health information technology and clinical research. IQVIA is a provider of biopharmaceutical development, professional consulting and commercial outsourcing services, focused primarily on Phase I ...
Clinical data management ( CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. [1] Clinical data management ensures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and ...
The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient. All data on each patient participating in a clinical trial are held and/or documented in the CRF, including adverse events . The sponsor of the clinical trial develops the CRF to collect the specific data they need in ...
An electronic patient-reported outcome ( ePRO) is a patient-reported outcome that is collected by electronic methods. ePRO methods are most commonly used in clinical trials, but they are also used elsewhere in health care. As a function of the regulatory process, a majority of ePRO questionnaires undergo the linguistic validation process.
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