Building the Evidence Base for eSource at Scale

woman in scrubs holding up a stethoscope in the shape of a heart

Building the Evidence Base for eSource at Scale

As clinical trials become more digital, the conversation around eSource is evolving. The question is no longer simply whether EHR-to-EDC technology can work—it’s how the industry can consistently measure whether implementations are delivering meaningful value across sites, sponsors, and technology environments.

A new article in Applied Clinical Trials, “Building Standardized Evidence for eSource-Enabled Clinical Trials: Multi-Site Validation of a Clinical Research Coordinator Satisfaction Methodology,” explores an important step toward answering that question. The study presents the first multi-site validation of a standardized methodology developed by the i~HD eSource Scale-Up Task Force for measuring Clinical Research Coordinator (CRC) experience with eSource-enabled clinical trials.

Across five leading academic oncology research centers in North America and Europe, researchers collected 28 responses from CRCs with hands-on experience using eSource-enabled workflows. The findings were encouraging: overall CRC satisfaction reached 5.79 out of 7, with an 84% positive response rate. Eight of nine measured areas exceeded the predefined positive implementation threshold, with CRCs reporting particularly positive experiences related to workflow efficiency, electronic data transfer, reduced manual data entry, and overall job satisfaction.

But the bigger story goes beyond satisfaction scores.

Today, eSource evidence is often generated through individual pilots and case studies using different measures of success, making it difficult to compare results across organizations. A standardized, technology-independent methodology creates the opportunity to build a cumulative evidence base, one that can support benchmarking, identify opportunities for improvement, inform investment decisions, and help the industry understand what successful eSource implementation looks like at scale.

As the article concludes, “Interoperability enables implementation; standardized evidence enables adoption.”

Read the full article in Applied Clinical Trials to explore the findings and what standardized evidence generation could mean for the future of eSource-enabled clinical research.

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