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Concept
Electronic data capture
Résumé
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. EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices. EDC solutions are widely adopted by pharmaceutical companies and contract research organizations (CRO).
Typically, EDC systems provide:
a graphical user interface component for data entry
a validation component to check user data
a de-identification component to make data less identifiable
a reporting tool for analysis of the collected data
EDC systems are used by life sciences organizations, broadly defined as the pharmaceutical, medical device and biotechnology industries in all aspects of clinical research, but are particularly beneficial for late-phase (phase III-IV) studies and pharmacovigilance and post-market safety surveillance.
EDC can increase data accuracy and decrease the time to collect data for studies of drugs and medical devices. The trade-off that many drug developers encounter with deploying an EDC system to support their drug development is that there is a relatively high start-up process, followed by significant benefits over the duration of the trial. As a result, for an EDC to be economical the saving over the life of the trial must be greater than the set-up costs. This is often aggravated by two conditions:
that initial design of the study in EDC does not facilitate the decrease in costs over the life of the study due to poor planning or inexperience with EDC deployment; and
initial set-up costs are higher than anticipated due to initial design of the study in EDC due to poor planning or experience with EDC deployment.
The net effect is to increase both the cost and risk to the study with insignificant benefits. However, with the maturation of today's EDC solutions, much of the earlier burdens for study design and set-up have been alleviated through technologies that allow for point-and-click, and drag-and-drop design modules.
Source officielle
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