Advancing Clinical Trial Efficiency and Data Accuracy through Direct EHR-to-EDC Integration

For study sponsors, clinical trial efficiency and data accuracy are non-negotiable drivers of success. Despite broad digitization in healthcare, redundant data entry persists, and the current reliance on manual transcription from electronic health records (EHRs) into electronic data capture (EDC) systems creates unnecessary complexity- leading to higher costs, site burden, and data quality risks. With the growing maturity of interoperability standards and frameworks, direct EHR-to-EDC integration offers a transformative opportunity to automate data transfer, improve accuracy, and streamline operations. This paper evaluates the impact of direct EHR-to-EDC integration on data quality compared to traditional workflows. Our findings in a multi-study, multi-site assessment demonstrate that manual transcription resulted in an error rate of 8.23% (95% CI: 7.79-8.70), whereas no transcription errors were detected in the integrated EHR-to-EDC workflow (95% CI: 0.00-0.03). These results underscore the potential of interoperability-based automation to improve data reliability and operational efficiency in clinical research.