February 2, 2026
i-Cubed Demonstrates AI-Driven Clinical Trial Automation in Major Proof-of-Concept Study
i-Cubed, the center for clinical research innovation at the Duke Clinical Research Institute (DCRI), has reached a major milestone in its effort to reimagine how clinical trials are run, completing a successful proof-of-concept study that demonstrates how AI can automate large portions of clinical trial operations faster, more consistently, and with built-in quality and compliance controls.
Project Loom, one of i-Cubed’s flagship R&D initiatives, was designed to answer the question: Can AI take on the most time-consuming and error-prone parts of running a clinical trial without sacrificing scientific rigor or regulatory integrity?
To explore that question, i-Cubed collaborated with technology partners Health Universe, Maxis AI, and Areti Health, combining each partner’s AI capabilities with DCRI’s deep expertise in trial design, regulatory requirements, and clinical operations. Working in parallel, the teams developed AI-enabled workflows capable of supporting key trial activities within a few weeks.
Those agentic workflows were then evaluated in a rigorous proof-of-concept study using a simulated version of a previously completed clinical trial. Each system was asked to perform a wide variety of clinical trial functions, including generating study documents, preparing and making IRB submissions, screening and enrolling virtual participants, capturing patient-reported outcomes, building electronic case report forms and data capture systems, extracting data from synthetic electronic health records, and producing a clinical study report. Performance was evaluated on time to completion, output quality, accuracy, and user experience. Final, cross-platform analyses are still underway, but the systems successfully executed the full end-to-end trial workflow.
“What made this project unique was that we weren’t just proving AI could generate content — we were proving it could serve as a central platform, orchestrating multiple AI agents that execute coordinated trial operations inside a real-world regulatory and scientific framework,” said Health Universe CEO Dan Caron.
“Working alongside DCRI and i-Cubed, we were able to show that complexity across data and workflows is not only manageable, but solvable with a speed and reliability that can transform the economics of clinical trials,” Maxis AI CEO Moulik Shah added.
From the participant lead sourcing and engagement perspective, Paul Neyman, Areti Health Co-Founder, said, “Participant engagement is one of the hardest parts of running a trial. This project showed how AI autonomously orchestrates the entire enrollment journey — medical chart matching, participant education, scheduling, consent, ePRO, etc. — meeting participants across text, voice, and web. What this unlocks is dramatically faster enrollment, more consistent, human-centered experiences, higher data quality, and clinical teams who can finally focus on patients instead of logistics.”
“Clinical trials are the engine of medical progress, but they are still built on slow, manual, and fragmented processes,” said principal investigator Christoph Hornik, MD, MPH. “This project shows that AI can be harnessed responsibly to modernize that engine — and we’re just getting started.”
For i-Cubed, Project Loom exemplifies its mission: to leverage the unique expertise and resources of the DCRI and turn ideas into tools, technologies, and processes that transform how clinical research is done — for the benefit of people everywhere.
To learn more about Project Loom, visit: Projectloom.org
About i-Cubed
i-Cubed™ is the center for clinical research innovation, powered by the unique expertise and resources of the Duke Clinical Research Institute. i-Cubed supports individuals, teams, and organizations in turning their ideas into tools, technologies, and processes that transform how clinical research is done — for the benefit of people everywhere.
About Areti Health
Areti Health is a venture-backed Silicon Valley AI technology company transforming how clinical research identifies, engages, and advances patients through trials. Its core innovation is an AI-driven Coordinator that is the only full-service trial automation AI agent performing medical record matching, 24/7 patient interaction, scanning clinical data, engaging candidates across voice and text channels, pre-qualifying prospects, scheduling next steps, performing consents, collecting ePROs, and nurturing participation with empathetic, intelligent responses. Areti’s conversational, generative, and agentic AI Coordinator capabilities integrates into with EMRs, CRMs, and clinical systems and workflows to accelerate recruitment, reduce screen failure rates, manual burden, and improve operational predictability by eliminating routine manual work. Learn more at [www.aretihealth.com].
About Health Universe
Health Universe is clinical AI infrastructure that enables healthcare organizations to deploy AI-powered workflows for clinical operations, research, and care delivery. The platform's multi-agent orchestration technology automates complex clinical processes from trial document preparation and patient identification to oncology summarization while maintaining regulatory compliance and quality standards. Health Universe serves EHR vendors, hospitals, payers, and life sciences organizations, with partnerships including academic medical centers and oncology care networks. Through its Navigator clinical AI companion and workflow automation capabilities, Health Universe helps free clinicians and researchers from administrative burden so they can focus on advancing patient care. Learn more at [www.healthuniverse.com].
About Maxis AI
Maxis AI is pioneering the future of clinical development with its Agentic AI platform, creating a hybrid, human-AI workforce, where intelligent AI agents and augmented human experts collaborate to conquer complexity. We empower life sciences organizations to move beyond the linear model of rising costs and timelines, enabling them to orchestrate trials with unprecedented speed, precision, and trust. Built upon the foundation of 3300 plus clinical trials’ execution experience and domain context, our enterprise-ready Agentic AI platform is "Designed to Think. Built to Act.,". It automates and optimizes end-to-end workflows, from study start up to regulatory submissions. We provide a fully governed, compliant, and integrated ecosystem that transforms human intent into intelligent action, delivering measurable results and accelerating the entire drug development lifecycle. Our mission is to transform the operating model of clinical research, ensuring that the most innovative therapies reach patients faster. Maxis AI serves pharma, biotech, medical devices, and CROs of all sizes, with partnerships including academic medical centers and site networks. [www.maxisai.com].
