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. 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 clinical research organizations (CRO).

Typically, EDC systems provide:

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 the 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:

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. With little to no programming required, and reusability from global libraries and standardized forms such as CDISC's CDASH, deploying EDC can now rival the paper processes in terms of study start-up time. As a result, even the earlier phase studies have begun to adopt EDC technology.

EDC is often cited as having its origins in another class of software — Remote Data Entry (RDE) that surfaced in the life sciences market in the late 1980s and early 1990s. However its origins actually begin in the mid-1970s with a contract research organization known then as Institute for Biological Research and Development (IBRD). Dr. Richard Nichol and Joe Bollert contracted with Abbott Pharmaceuticals for the IBRD 'network' of Clinical Investigators to each have a computer and 'directly' enter clinical study data to the IBRD mainframe. IBRD then cleaned the data and provided reports to Abbott.

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