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.
Support prospective biospecimen collection within pragmatic study designs, enabling correlative analyses that link biomarker data to clinical outcomes across a research-ready site network.
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.
