As oncology therapies mature, post-approval research is essential to supporting regulatory commitments, label expansion, and real-world adoption—often under tight timelines. Yet many post-approval studies still rely on trial models built for investigational drugs, introducing unnecessary complexity, restrictive eligibility, and workflows misaligned with routine care, resulting in slower enrollment, limited representativeness, higher costs, and delayed insights.
With increasing regulatory flexibility and advances in healthcare data and technology, post-approval research can now be more pragmatic—embedded in real-world care while maintaining the rigor required for regulatory and medical decision-making.
A new model for post-approval research
Paradigm Health’s Scalable Platform for Integrated Resarch & Evidence (SPIRE) defines a new model for post-approval research by applying prospective, embedded study principles to late-stage and approved therapies. This model is designed to support post-marketing commitments, label expansion, and medical evidence generation by aligning evidence development to routine clinical care while maintaining the rigor required for regulatory and medical decision-making.
Prospective evidence, designed for impact
Planned with intent
Study objectives, endpoints, and analyses are defined in advance, closing the rigor gap for post-marketing decisions beyond retrospective evidence.
Embedded in routine care
Patients are enrolled and followed through existing clinical workflows, reducing activation timelines and avoiding the overhead of traditional trials.
Built for post-approval assets
Well-suited to post-marketing commitments and label expansion for approved therapies, while addressing real-population effectiveness questions.
Designed for broad participation and low burden
Supports broader, more representative participation across community and academic settings while minimizing site workload.
Design smarter protocols, recruit faster, and capture high quality data
Paradigm Health operationalizes this prospective, embedded research model through its integrated trial design, recruitment, and study conduct capabilities. Leveraging a unified technology platform, a research-ready, tech-enabled provider network, and end-to-end operational services, SPIRE enables the execution of late-stage and post-approval studies efficiently within routine oncology care.
Trial design & protocol optimization
Pragmatic protocols built from data-driven patient population insights and designed for execution in community oncology settings.
- Protocols tailored to the maturity of the therapy and the research objective
- Eligibility criteria, endpoints, and assessments aligned to routine clinical care
- Focused data collection supporting late-stage and post-approval decisions
- Designed to retain scientific rigor while reducing unnecessary burden on patients and sites
Recruitment platform & expert coordinator capacity
Embedded, AI-driven patient identification and recruitment coordination support within routine care workflows.
- AI-enabled identification of eligible patients directly from the EHR
- Screening integrated into routine care delivery
- Centralized pre-screening and patient navigation with minimal disruption
- Broader, more representative participation across community and academic sites
EHR-integrated study execution and data capture
Prospective data capture embedded in care delivery through the Paradigm Health network of technology-enabled sites.
- EMR-integrated eSource aligned to clinical documentation
- Prospective capture of clinical data as care is delivered
- Streamlined workflows to reduce manual entry and site workload
- Consistent data quality and oversight across distributed sites
Delivering value across post-approval needs
Paradigm Health Prospective Evidence supports a range of post-approval research needs by applying pragmatic study design, embedded recruitment, and technology-enabled data capture to generate high-quality evidence more efficiently.
Label expansion
Expand into new indications, populations, or dosing strategies through pragmatic study designs aligned to routine clinical care that don’t add burden.
FDA post-marketing commitments and requirements
Execute fit-for-purpose prospective studies that meet regulatory requirements efficiently, with scalable enrollment and high-quality data capture.
Post-approval evidence & registries
Generate prospective clinical evidence and support registry-based studies to inform differentiation, payer engagement, guideline development, and broader clinical adoption.
