Protocol-Driven eSource Advances Study Efficiency

In a recent video interview with Applied Clinical Trials, Jonathan Andrus, co-CEO of CRIO, discussed how 2026 is expected to mark a continued shift toward site-based technologies and protocol-driven eSource to improve data quality, compliance, and trial efficiency. He emphasized the importance of capturing high-quality data at the point of patient encounter, reducing fragmentation across sites, and enabling real-time data access and monitoring. Andrus also highlighted the growing need for cross-functional collaboration during protocol design, stronger governance across the data lifecycle, and increased use of AI to streamline study build, data review, and operational workflows.

Editor's note: This transcript is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

ACT: How do you expect eClinical platforms to evolve in 2026 to better support data quality, oversight, and study efficiency?

Andrus: Building on that, one of the key elements will be sponsors providing sites with protocol-driven eSource tools—essentially electronic source data collection systems based on standardized templates derived directly from the study protocol.

What that means is taking the protocol and translating it into structured data collection templates that are distributed across all participating sites. This ensures consistency in how data are collected and reinforces quality at the point of patient encounter.

These tools include built-in logic, edit checks, and cross-form validation, so when a coordinator is sitting with a patient, they can be confident the data being captured aligns with protocol requirements. That’s a major shift from current approaches, where EHRs may contain relevant data but are not tied to protocol-specific requirements, and paper systems have no logic or validation at all.

At the same time, it’s important that sites maintain flexibility. They still need the ability to incorporate local workflows or procedures—such as pre-screening steps—into the system. So the balance is standardization through central templates, combined with flexibility for site-specific needs.