EHR-To-EDC Integration

OpenClinica Unite™ is a ground-breaking technology that delivers on the promises of EHR and EDC integration. It can function either as middleware (the bridge between your EDC and your sites’ EHRs) or as an end-to-end eClinical software suite. In both capacities, OpenClinica Unite™ utilizes the study protocol to map directly to the requisite data in the EHR—filtering for just what the protocol requires. Study team members can initiate data transfers in a few simple clicks. Once auto-populated with data from the EHR, the eCRF becomes a certified and immutable copy of the source data, meeting the FDA requirements for source data. Automated source data capture greatly reduces the need for SDV because it creates a transparent, traceable, and tamperproof path back to the source data originator. The result is lower costs for sponsors, reduced site burden, and faster time to market.

Quality, safety, and speed are the lifeblood of clinical development. Capitalizing on EHR-to-EDC integration helps sponsors:

• Accelerate decision making and time to market
• Obtain finalized data faster
• Acquire more precise, fine-grained data
• See potential safety signals sooner
• Cut down on costly cycles of SDV

Integration lowers the burden for sites to participate in research, potentially increasing their enthusiasm to join studies and recruit patients. Automated data acquisition from electronic records is now practical for use in clinical trials, promising benefits to both sponsors and sites. Digital first will become the new norm in clinical research as it has in many other aspects of our lives.

OpenClinica Unite™ automates source data acquisition from patient medical record systems (EHRs) to clinical trial research databases (EDCs) and case report forms (eCRFs). This secure bridge between healthcare and research eliminates manual data transcription and is especially suited for rigorous GCP and Part 11-compliant clinical trials. OpenClinica Unite is backed by a rapidly growing network comprising over 300 sites across leading health systems.

"The OpenClinica Unite app performs exactly as expected, enabling the pulling of laboratory and medication data from our EHR at the click of a button. These features save an enormous amount of time for our clinical research coordinators, simultaneously eliminating data entry errors. Our site is now much better equipped to keep up with the demands of a data-rich clinical trial, providing key results to the study sponsor much more promptly."

- Principal Solutions Architect