CRIO’s New AI eSource Builder Speeds Up Study Builds While Keeping Site Teams in Control

Early adopter sites have cut build time by an average of four hours per trial, easing one of the most time-consuming steps in study start-up

BOSTON, MA / ACCESS Newswire / October 13, 2026 / CRIO, the leading provider of eSource technology for clinical research, is rolling out AI eSource Builder, a new product that creates an initial draft of a research site’s eSource study build from the protocol, supporting documents and site preferences.

Source preparation is a largely invisible bottleneck in clinical trials. In a study published this year by the Tufts Center for the Study of Drug Development, at least 80% of sites reported that preparing source documents for high-complexity trials takes more than 21 hours, and 77% said the specialized skills needed to translate protocols into source documents constrain their organizations.

At early adopter sites, AI eSource Builder is saving an average of 4 hours on each study build, and those savings grow over time through a built-in feedback loop. Every finished build, including the changes a site’s team makes during review, informs how the builder drafts that site’s next study, so each new build starts closer to how the site works. Study designers review and refine every draft, then finalize it in CRIO before it goes live. No build reaches a study without human review.

“Most of the conversation about AI in clinical research is about what it can take off people’s plates. The more important question is what it should never take off their plates,” said Jonathan Andrus, Co-CEO, CRIO. “Judgment about how a study runs belongs to site teams, and AI eSource Builder gives them a faster start so they can focus on the areas where their time and expertise are needed most. AI works best when it does one well-defined job well, inside the systems sites already use, with a person reviewing every output.”

Sites upload their protocols along with blank or annotated electronic case report forms (eCRFs) or eCRF completion guidelines. AI eSource Builder reads the Schedule of Assessments and generates an initial version with visits, windows and procedure templates already in place, pulling from both the site’s own templates and CRIO’s global templates.

Build rules decide how those templates come together. CRIO provides a starting set of 150+ build rules, drawn from its experience supporting thousands of studies, that each site can adjust and extend. The same rules apply across every study, so each new build follows the site’s standards no matter who builds it.

“Participating in CRIO’s AI eSource Builder Early Release Program has been a great experience,” says Amber Victor, VP Operations at Elevate Clinical Research, “The builder is intuitive, efficient, and has the potential to significantly reduce the time required to build eSource while improving consistency across our studies.”

AI eSource Builder works only with study design documents, such as protocols and eCRFs, so no electronic protected health information (ePHI) or subject-level data is ever involved. CRIO’s agreements with its AI model providers prohibit training on customer data, and models receive only the sections of a document needed for each task.

“Sites and sponsors want to know two things about any AI tool: where their data goes, and who makes the decisions,” said Marc Wartenberger, VP of Compliance & Security, CRIO. “AI eSource Builder was built so both answers are simple. Study documents stay protected, and qualified site staff review, edit and approve every element before anything goes live. The site remains accountable for its source, exactly as it is today.”

AI eSource Builder is the latest step in CRIO’s ongoing work to apply AI where it can meaningfully reduce site burden without touching the judgment that belongs to site teams.

“We saw applied AI as a big opportunity to help sites with study builds, and we see even bigger opportunities once a study is running,” said Mike Wenger, Chief Innovation Officer, CRIO. “We’re actively building new AI tools that will save sites time and improve data quality throughout the study.”

About CRIO
CRIO is the leading provider of eSource solutions for clinical research. Built for sites and trusted by sponsors and CROs worldwide, we have replaced paper-based source documentation with integrated eSource, eConsent, eRegulatory, and CTMS tools. Our platform drives faster site startup, higher enrollment, fewer protocol deviations, stronger data integrity, and enhanced patient safety. CRIO’s digital-first, site-centric approach powers 7,000 protocols across 4,000 sites around the globe. Learn more at clinicalresearch.io.

Media Contact
Brook White
brook.white@clinicalresearch.io

SOURCE: CRIO

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