For clinical research sites, manual data entry remains a substantial burden that drains resources and increases study timelines. This impact is worsening as clinical trials become increasingly complex, with more endpoints, procedures, inclusion/exclusion criteria, and data sources. Electronic health record (EHR) and eSource integration has potential to lower this site burden—as well as to reduce trial costs, accelerate study completion, enable earlier identification of safety events, reduce overall operational overhead, and improve the overall trial experience for sites.
As much as 70% of the data entered into electronic data capture (EDC) systems originate from EHRs and other sources, explains Samir Jain, Vice President, Product Management, Healthcare Data Interoperability and EHR Solutions, Medidata, Dassault Systèmes. “By addressing challenges involving interoperability, ensuring data quality, and streamlining data transfer processes, researchers can benefit from improved and smarter workflows within their EDC systems,” he says.
“As well as requiring time and effort, routine data entry and re-entry can introduce human error,” notes Jain. “In turn, this generates a ripple effect, requiring the sponsor to invest in validating the data, and researchers having to correct submissions. This problem has existed since these systems were introduced more than 20 years ago. However, its impact is more marked in today’s highly complex studies, and with a push for sites to ‘do more with less.’”
Sites are demanding better clinical workflows and lower operational costs. With reductions in government funding, academic institutions in particular need to work smarter not harder. Researchers are becoming more open to EHR-to-EDC integration and other efficiencies, with sponsors increasingly supporting these approaches.
“An important step is to make it easier for sites to adopt these types of technology, at scale,” according to Jain. “Any solution must be able to achieve a return on investment quickly by benefiting multiple sponsors and studies. It must also fit into existing workflows, meeting users where they are and minimizing the change management required.”
Site-First eSource: Practical Strategies for EHR-to-EDC Adoption
Join Samir and Milijana Ugrenovic-Petrovic at ACRP 2026 [April 24-27; Orlando, Fla.] as they explores what it really takes to make eSource and EHR-to-EDC work for sites: no new systems, no additional logins, no information technology support. View complete schedule.
“Sites can think of EHR-to-EDC integration as a supervised, assistive workflow that keeps them in the loop but can take the rote manual work out of the process,” states Jain. “Humans will continue to be involved, working more efficiently thanks to this tool.”
Jain concludes, “Based on learnings from dozens of sites and sponsors, EHR-connected workflows can save time, reduce errors, and improve monitoring through traceable data capture. Bringing EHR integration to sites at scale, especially when built into their EDC system, can make data entry easier without the need for new systems, additional logins, or extra time spent mapping data.”
Edited by Jill Dawson
