EHR-To-EDC Integration: Proof Points

By Cal Collins

OpenClinica’s Unite™, the EHR-to-EDC (Electronic Data Capture) solution, showcased at the 5th Annual CERSI Innovations in Regulatory Science Summit, demonstrates the power of automated data capture within clinical trials. Using the SMART on FHIR integration framework, Unite integrates seamlessly with EHR systems, enabling real-time, regulatory-grade data transfer to eCRFs. In the I-SPY COVID platform trial, Unite demonstrated a significant impact on data entry efficiency and quality: automated capture of 8,099 eCRFs reduced data entry time by 45.8%, saving approximately 2,300 hours if implemented across sites from trial inception.

The study highlighted the improved accuracy and efficiency of automated data capture. Unite’s deployment within the patient EHR and flexible integration allows clinical trial sponsors to minimize costly errors and accelerate timelines. This scalable, cost-effective solution emphasizes high data quality, faster data access, and improved site staff satisfaction—setting a new standard for regulatory-grade clinical research.