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Electronic Data Capture (EDC) is now the preferred technology which provides significant benefits over traditional, manual data entry methods. In a recent guidance (Sept 2013) the FDA promotes capturing source data in electronic form, ensuring the reliability, quality, integrity, and traceability of data from electronic source all the way through to electronic regulatory submission.
The adoption of an eSource system to run a clinical pharmacology unit goes beyond simple EDC, it is about complete clinic automation. In this presentation we will share implementation experiences, benefits, and lessons learned while replacing paper source at the clinical unit through embedding eSource in all operational processes, from set-up of the eSource to delivery of SDTM compliant datasets.
Updated October 2014 with new figures.