COLUMBUS, Ohio and NEW YORK, April 21, 2026 /PRNewswire/ — Paradigm Health today announced SPIRE — Scalable Platform for Integrated Research & Evidence — a new model for post-approval and late-stage clinical studies designed to help sponsors generate prospective clinical evidence faster, more predictably, and with greater real-world representativeness.
SPIRE is built as a full-scale alternative to traditional post-approval study models. By combining pragmatic study design, streamlined patient recruitment, and EHR-integrated data capture across a network of research-ready community and academic sites, SPIRE enables sponsors to run studies that are better aligned to routine care while reducing burden on research staff and patients.
Post-approval evidence generation has often forced sponsors to choose between speed, rigor, and representativeness. SPIRE is designed to change that; maintaining rigor while leveraging technology and study design to reduce burden and accelerate recruitment. The platform supports key regulatory objectives including label expansion, post-marketing commitments and requirements, and other late-stage evidence needs by making it easier to conduct prospective studies with highly pragmatic designs that better reflect routine care.
“Post-approval studies should not require sponsors and providers to sacrifice scientific value for operational feasibility,” said Kent Thoelke, CEO of Paradigm Health. “SPIRE brings research directly into the flow of care with pragmatic protocols, embedded recruitment, and EHR-integrated execution, helping generate the high-quality evidence sponsors need while expanding access to more representative patient populations.”
SPIRE’s model has already been used by top pharmaceutical companies in late-phase studies, including in a post-approval trial conducted at four community oncology practices to evaluate infusion-related adverse events for multiple myeloma patients treated with an FDA-approved therapy. Researchers published an assessment of the quality of data captured using an eSource solution and found that the tech-enabled model could transfer a large volume of high-quality data, reducing time for data cleaning and clarification, and rapidly enrolling a representative patient population.
Paradigm Health, along with a pharmaceutical sponsor and a team of multi-site researchers, will present another use of the SPIRE model at the American Society for Clinical Oncology’s (ASCO) Annual Meeting on June 1, 2026. The presentation will highlight SPIRE’s operational benefits in a poster titled “A pragmatic, hybrid observational study evaluating the effectiveness of trastuzumab deruxtecan (T-DXd) in patients with human epidermal growth factor receptor 2 (HER2) immunohistochemistry (IHC) 3+ solid tumors: DESTINY-PanTumor04.”
SPIRE builds on Paradigm Health’s category-leading technology platform, including its clinical trial matching and recruitment solution and its study conduct offering, eSource Casebook, along with a network of more than 160 U.S. health provider organizations equipped with these capabilities.
About Paradigm Health
Paradigm Health has engineered an AI-powered platform to make clinical trials more accessible and efficient, so that patients, researchers, and study sponsors can maximize the impact of clinical research. Incubated by ARCH Venture Partners and backed by leading healthcare and life sciences investors, Paradigm Health aims to break down barriers across the trial ecosystem through one seamless infrastructure implemented at healthcare provider organizations, bringing potentially life-saving therapies to patients faster. For more information, visit https://www.paradigmhealth.ai.
About SPIRE
Scalable Platform for Integrated Research and Evidence (SPIRE) is an end-to-end, technology-enabled alternative to traditional CRO-led approaches for prospective, pragmatic studies, particularly for peri-approval and post-approval products with established safety profiles.
The solution combines:
- EHR-integrated technology embedded directly into patient visits, in community, rural, and academic settings across 46 states
- Data-driven study design and site selection informed by care patterns and site capabilities
- Full-service study conduct support across site selection, startup, enrollment, data management, safety, and closeout
SPIRE Intended Use Cases
SPIRE is intended for prospective, pragmatic U.S. studies for assets that are approved of nearing approval, including:
- Post-marketing requirements and commitments with observational designs
- Phase IV safety and/or effectiveness
- Label expansion
- Comparative effectiveness
- Prospective registries and external control arms
- Hybrid studies incorporating randomized and pragmatic elements
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SOURCE Paradigm Health, Inc.
