Paradigm Health Launches SPIRE Platform to Transform Post-Approval Clinical Evidence Generation
Key Insights
Paradigm Health (search) announced SPIRE (search), a new technology-enabled platform designed to accelerate post-approval and late-stage clinical studies while maintaining scientific rigor and improving real-world representativeness.
The platform combines pragmatic study design, EHR-integrated data capture, and streamlined patient recruitment across a network of over 160 U.S. health provider organizations in 46 states.
SPIRE (search) has already demonstrated success in post-approval trials, including a multiple myeloma (search) study that showed improved data quality and faster patient enrollment compared to traditional approaches.
Paradigm Health (search) announced the launch of SPIRE (search) (Scalable Platform for Integrated Research & Evidence), a technology-enabled platform designed to transform how pharmaceutical companies conduct post-approval and late-stage clinical studies. The platform addresses longstanding challenges in post-approval evidence generation by combining pragmatic study design, streamlined patient recruitment, and EHR-integrated data capture across a network of research-ready community and academic sites.
Addressing Traditional Trade-offs in Post-Approval Studies
Post-approval evidence generation has historically forced sponsors to choose between speed, rigor, and representativeness. SPIRE (search) is designed to eliminate these trade-offs by maintaining scientific rigor while leveraging technology and study design innovations to reduce operational burden and accelerate patient recruitment. The platform enables sponsors to conduct prospective studies with highly pragmatic designs that better reflect routine clinical care.
"Post-approval studies should not require sponsors and providers to sacrifice scientific value for operational feasibility," said Kent Thoelke, CEO of Paradigm Health (search). "SPIRE (search) 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."
Platform Capabilities and Infrastructure
SPIRE (search) operates as a full-scale alternative to traditional CRO-led approaches for prospective, pragmatic studies, particularly for peri-approval and post-approval products with established safety profiles. The platform integrates EHR technology directly into patient visits across community, rural, and academic settings in 46 states, supported by data-driven study design and site selection informed by care patterns and site capabilities.
The solution provides comprehensive study conduct support across site selection, startup, enrollment, data management, safety monitoring, and study closeout. SPIRE (search) builds on Paradigm Health (search)'s existing technology infrastructure, including clinical trial matching and recruitment solutions and the eSource Casebook platform, deployed across a network of more than 160 U.S. health provider organizations.
Proven Clinical Applications
SPIRE (search)'s effectiveness has been demonstrated in real-world applications with top pharmaceutical companies. In one post-approval trial conducted at four community oncology practices, researchers evaluated infusion-related adverse events for multiple myeloma (search) patients treated with an FDA-approved therapy. The study assessment showed that the tech-enabled model could transfer large volumes of high-quality data while reducing time required for data cleaning and clarification, and achieved rapid enrollment of a representative patient population.
Upcoming ASCO Presentation
Paradigm Health (search) will present additional SPIRE (search) model results at the American Society for Clinical Oncology (search) (ASCO (search)) Annual Meeting on June 1, 2026. The presentation will highlight operational benefits through 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 (search) (HER2 (search)) immunohistochemistry (IHC) 3+ solid tumors: DESTINY-PanTumor04."
Target Applications and Regulatory Support
SPIRE (search) is designed to support key regulatory objectives including label expansion, post-marketing commitments and requirements, and other late-stage evidence needs. The platform is intended for prospective, pragmatic U.S. studies for approved or near-approval assets, including post-marketing requirements and commitments with observational designs, Phase IV safety and effectiveness studies, label expansion studies, comparative effectiveness research, prospective registries and external control arms, and hybrid studies incorporating both randomized and pragmatic elements.