AI in eCOA: What Works. What Breaks.

AI in eCOA: Machine Translation — The Good, The Bad and The Unknown

AI is being applied across clinical trials, but in eCOA localization it is not a plug-and-play solution. Used correctly, it can improve speed and consistency; used incorrectly, it creates rework, delays, and risk to endpoint quality. Join Castor, RWS, and Safira to explore what works and what fails when applying AI to this complex process. Free. 60 minutes. Thursday, 11 June at 10 AM EDT.

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What this session covers

AI is being pushed into eCOA localization, but most teams are still figuring out how to apply it effectively. Hosted by Castor, this session brings together Dan Herron from RWS and Willie Muehlhausen from Safira to share where AI is delivering real value today and where it is falling short, based on practical delivery experience. There are clear areas where AI adds value, particularly in migration workflows, QC, and consistency checks, where automation can help reduce timelines when applied correctly. However, there are also critical areas where AI does not replace expertise. Cultural adaptation, cognitive debriefing, and clinical review still require human judgment, and treating these as fully automatable is a key driver of rework and delays. We will also address a common issue across studies, where teams assume that validated paper translations can be reused in eCOA with minimal effort. In reality, this requires structured migration and validation to maintain equivalence and usability in a digital format. This session provides a practical, experience-led perspective on how to apply AI in a way that improves delivery rather than disrupts it.

A brief walkthrough of the traditional eCOA localization and migration process
What works (and what fails) when applying AI to eCOA localization
Best practices for handling validated and certified assessments
The biggest industry misconceptions causing trial delays
Realistic outcomes and impact areas for localization automation

Who this is for – Built for global trial teams managing localized instruments

Clinical operations leads

Managing multi-site global trials where eCOA localization timelines directly affect study start dates and data collection windows.

eCOA and ePRO program managers

Responsible for instrument migration, translation validation, and ensuring digital deployments maintain the equivalence of paper-validated tools.

Regulatory affairs professionals

Navigating the intersection of AI-assisted localization, linguistic validation requirements, and the documentation needed to support regulatory submissions.

Frequently Asked Questions

Can machine translation be used for eCOA localization?
AI machine translation can accelerate specific tasks in eCOA workflows, particularly migration quality control and consistency checks. However, cultural adaptation, cognitive debriefing, and clinical review of patient-reported outcomes still require human expert judgment. Applying machine translation to tasks that require linguistic validation creates rework and regulatory risk. This session maps exactly where the boundary sits, drawing on new research from RWS and practical migration experience from Safira.
Why can't validated paper translations be reused directly in eCOA?
Migrating validated paper instruments to electronic data capture is not a copy operation. Equivalence requirements differ in a digital format — the way a patient interacts with a question on screen changes response behavior. Structured migration and validation are required to maintain equivalence and usability in a digital format. Skipping this step is one of the most consistent sources of regulatory risk and timeline delay in global trials.
Will this session be available on demand after June 11?
Yes. The session will be recorded and made available on demand after the live broadcast on 11 June 2026. Register at this page to receive the on-demand link once the recording is live.
Who is presenting?
Lisa Charlton, PhD MBA from Castor hosts the session. Dan Herron from RWS brings global life sciences localization expertise and new research findings on machine translation in clinical workflows. Willie Muehlhausen from Safira contributes specialist eCOA migration experience. All three perspectives are grounded in active delivery work, not theory.