Why Pharma Needs an EHR to EDC Connection
Manual data entry and manual verification of data entered into EDC, is 100% manual and can be one of the most problematic issues in clinical trials. The problems revolve around correct identification of source (correct subject, correct visit, correct data) and data transcription.
Problems surrounding identification of source are known problems at the clinical site but are rarely understood let alone quantified by the pharma sponsor. Classically, transcription has been the only reliable, brute force method to get data into your EDC – it works across all source data modalities. Transcription works, but there are significant limitations, namely the human element.