March 25, 2026

SPARK Grant Supports i-Cubed Vision for AI-Driven, End-to-End Clinical Trials

What if agentic AI could provide end-to-end support for clinical trial execution? i-Cubed is one step further to realizing this dream so that clinical teams can apply their expertise where it matters most. 

A multi-disciplinary team, supported by i-Cubed and led by Principal Investigator Christoph Hornik, MD, PhD, has been awarded a Duke Science & Technology (DST) SPARK Seed Grant for their proposal to leverage AI to accelerate clinical trials.

Project Loom, one of i-Cubed’s flagship R&D initiatives, was designed to answer the question: Can AI support the most time-consuming and error-prone parts of running a clinical trial without sacrificing scientific rigor or regulatory integrity?

Project Loom is revolutionary and designed to thoughtfully integrate AI into clinical trial implementation in a way that strengthens, not replaces, human expertise. Clinicians, trialists, and operations leaders define trial intent, interpret protocols, and make the value-driven decisions that safeguard scientific validity, regulatory compliance, and, most importantly, patient safety. AI supports this work by taking on repetitive, time-intensive operational tasks, such as streamlining documentation, routing information, and standardizing processes, so teams can focus their energy where human judgment is essential. By reducing operational friction and freeing experts to identify risks early, manage complex relationships, and make nuanced decisions, Project Loom aims to accelerate the delivery of new therapies while preserving the rigor, compassion, and oversight that high-quality clinical research demands.

i-Cubed’s proposal was one of more than 130 submissions reviewed by the Office for Research & Innovation’s DST SPARK Seed Grant Selection Committee. Reviewers praised the project’s clarity, feasibility, and potential for broad impact, noting that it offers a promising opportunity for Duke to establish leadership in this important and rapidly evolving space. The award was facilitated through Duke's Office for Research and Innovation and the Office of the Provost and was funded through a combination of the Duke Discovery funding supporting science and technology and internal Duke funding.

“Clinical trials are the engine of medical progress, but they are still built on slow, manual, and fragmented processes,” said Hornik. “This project shows that AI can be harnessed responsibly to modernize that engine – and we’re just getting started.”

At i-Cubed, the Duke Clinical Research Institute’s center for clinical research innovation, this project is part of a growing portfolio of initiatives focused on improving the speed, cost, efficiency, and impact of clinical research. The project reflects the center’s mission to develop sustainable solutions that make clinical research seamless and impactful for everyone.

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.  
 
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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].  
 
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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].