Paradigm Health's Scalable Platform for Integrated Research & Evidence (SPIRE) is a full-scale alternative to traditional models, combining pragmatic study design, embedded recruitment, and EHR-integrated data capture across a network of research-ready sites to deliver faster, more predictable, and more representative post-approval clinical trials.
Sponsors face growing evidence expectations, but conventional approaches introduce unnecessary complexity, limited representativeness, and slower execution.
Post-approval studies often mirror early-phase complexity—driving cost, increasing site burden, and slowing execution without improving real-world relevance.
Looking backward at existing data may be faster, but it lacks prospective intent, standardized endpoints, and the regulatory confidence required for many post-approval objectives.
Many studies struggle to enroll diverse, real-world patient populations required for regulatory commitments, as traditional site models limit access to patients treated outside major academic centers.
Paradigm Health's model integrates pragmatic protocol design, AI-driven recruitment, and EHR-aligned study execution within a research-ready network of community and academic sites. The result: faster enrollment, greater representativeness, and high-quality prospective data—without adding unnecessary site and patient burden.
Pragmatic protocols aligned to routine oncology care
Endpoints designed for simplicity and maximum participation
AI-enabled patient identification based on real-time EHR data
Embedded recruitment across community and academic sites
EHR-integrated data capture to signficantly reduce manual entry
Centralized feasibility and start-up for streamlined execution and consistent oversight
Purpose-built to address regulatory, medical, and market access needs across late-stage and approved assets.
Expand into new indications, populations, or dosing strategies through pragmatic study designs aligned to routine clinical care that don't add burden.
Execute fit-for-purpose prospective studies that meet regulatory requirements efficiently, with scalable enrollment and high-quality data capture.
Generate prospective clinical evidence and support registry-based studies to inform differentiation, payer engagement, guideline development, and broader clinical adoption.
In a prospective pragmatic study conducted in U.S. community oncology sites, Paradigm Health helped the sponsor fulfill a post-marketing commitment with measurable gains in enrollment speed, cost efficiency and data quality.
Whether you're planning a post-marketing commitment, label expansion, or prospective evidence study, Paradigm Health can help you design and execute a pragmatic model aligned to routine clinical care.
Let’s explore how SPIRE can support your upcoming regulatory or medical evidence priorities.
