15 June 2026 · 4 min read · Webinar recap
The process for localizing patient questionnaires and getting them onto patients’ screens has barely changed in twenty years. The trials around it have changed completely. Studies that once rolled out five or ten languages at a time now launch in twenty to fifty, and real-world evidence studies increasingly ask for fifteen or more delivered simultaneously. Something has to give.
That tension framed AI in eCOA: What Works. What Breaks., a Castor webinar broadcast on June 11 and hosted by Lisa Charlton, PhD MBA, Chief Product Officer at Castor, with Dan Herron, Global Vice President of Linguistic Validation at RWS, and Willie Muehlhausen, Co-CEO of Safira. The hour mapped where AI fits across eCOA localization and translation, and the most valuable findings sit in the parts of the workflow few teams ask about: the handoffs, the migration, and the QC.
The bottleneck is the handoffs
On raw translation speed, the numbers are striking. Willie reported that AI-generated forward and backward translations now arrive in minutes rather than days, and Safira compares outputs from multiple language models to score which translation is strongest. Quality still varies sharply by language. Dan noted that major European languages are well served, while Zulu, Afrikaans, regional Indian languages, and Arabic, with its masculine and feminine forms, still trip the engines.
Speed at one step does not shorten a study, though. Dan’s central reframe is that eCOA localization is a fragmented, multi-step workflow spread across CAT tools, offline linguist reviews, and vendor handoff packages, and that fragmentation is why timelines have stayed flat for two decades. The biggest gains come from automating the handoffs. Describing proof-of-concept projects that ran four COAs into twenty languages, Dan put numbers on it:
The migration side of the workflow is moving just as fast. Lisa’s own focus is automating the generation of electronic migrations, the step where a paper-based instrument is built for electronic implementation while maintaining equivalency to paper source. AI can assist with pixel-to-pixel screenshot comparisons for migration QC, helping with confirmation of reuse. These are the unglamorous steps, layout checks, consistency reviews, screenshot QC, where automation saves real time without ever touching validated content. They matter because reusing a validated paper instrument in eCOA is not a copy job. Equivalence requirements change on screen, and skipping structured migration is one of the most consistent sources of rework in global studies.
Both guests drew an equally hard line around the human work. Cognitive debriefing interviews with patients, clinician review, cultural adaptation, and reconciliation decisions stay with people, a position that matches the ISOQOL task force recommendations published this February. For leadership teams that want AI to absorb the entire workflow, Dan offered the sentence that reliably turns those conversations around:
Willie expects that human-only zone to shrink sooner than most anticipate, pointing to research Safira completed in the past twelve months. He was just as clear about the bar for getting there:
The path forward is the one that took BYOD from heresy to a fixture of EMA guidance. Run pilots in parallel with the standard process, publish the evidence in peer-reviewed journals, and bring regulators along early. Dan’s advice to sponsors was blunt: do not wait for somebody else to master this first, because they may not.
What’s in the full recording
The hour goes well past this summary. Dan walks through the augmentation map, showing which localization stages welcome AI and which stay human-only (23:29). He surfaces a development most attendees had not heard: copyright holders are now writing anti-AI clauses into instrument license agreements (37:42). Willie makes the session’s most provocative argument, that the ISPOR “gold standard” was assembled from twelve older guidelines and never tested, so it “may not be that golden after all” (47:31). He also names the industry fix that needs no AI at all, sharing translation memories across sponsors (57:33), recounts the ten-year campaign of studies, publications, and FDA meetings that made BYOD acceptable (13:32), and explains why instruments written at a twelve-year-old reading level play straight into LLM strengths (51:28).
The full session is one hour, built for clinical operations leads, eCOA program managers, and regulatory affairs teams running multilingual studies on clinical trial solutions.
