arcoro Glossar

Electronic Data Capture (EDC)

Electronic Data Capture is an electronic data collection solution based on a computerized system. It is used to capture clinical data collected via surveys or clinical trials. Due to the new EU Medical Device Regulation, manufacturers of medical devices and pharmaceuticals must map the entire product life cycle and guarantee that the preparations fully fulfill their purpose and performance. Failure to provide this guarantee and traceability can result in loss of certification and withdrawal of the medical device from the market. Electronic data collection enables faster market approval and launch of drugs and medical devices by replacing the traditional paper-based process. Currently, however, mainly large pharmaceutical companies and research institutes use the electronic data collection variant. Smaller pharmaceutical companies and medical device manufacturers are often constrained by the high acquisition and operating costs of the EDC system. The solution allows access to graphical user interfaces for data entry, a validation tool, and a reporting tool to review and analyze the data obtained. Advantages of EDC include reduced data entry time and increased data quality.

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Sven J. Kolthof



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