Paradigm Health’s SPIRE platform streamlines post-approval oncology research with pragmatic, prospective studies embedded in routine care. Credit via Shutterstock
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.
