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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 medical devices.
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 ...
Remote data entry. A remote data entry ( RDE) system is a computerized system designed for the collection of data in electronic format. The term is most commonly applied to a class of software used in the life sciences industry for collecting patient data from participants in clinical research studies—research of new drugs and/or medical devices.
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 ...
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.
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.
ODM is a vendor-neutral, platform-independent format for interchange and archive of clinical study data. The model includes the clinical data along with its associated metadata, administrative data, reference data and audit information. [8] ODM was first introduced in 1999, and the latest version, 1.3.2, was released in 2012. [9]
There are many types of e-commerce models, based on market segmentation, that can be used to conducted business online.The 6 types of business models that can be used in e-commerce include: [1] Business-to-Consumer (B2C), Consumer-to-Business (C2B), Business-to-Business (B2B), Consumer-to-Consumer (C2C), Business-to-Administration (B2A), and Consumer-to-Administration