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OncoLattice does not buy, sell, or access identifiable patient information and does not identify or contact patients.
RWD-Enabled Cohort & Site Strategy
A compliance-aware workflow for cohort feasibility, protocol risk, and site strategy.
This advanced package converts real-world feasibility logic into sponsor-facing protocol and site strategy decisions. It is not a data resale product and does not imply access to identifiable patient information.
Service detail
The decision it helps you make
CROs may provide site lists and recruitment estimates, but sponsors may not know what assumptions support those estimates. This service asks whether biomarker availability, prior therapy patterns, competing trials, screen failure drivers, and patient distribution support the strategy.
What you share, what we review
- RWD question design that translates clinical development concerns into structured feasibility questions.
- Structured cohort definition covering cancer type, disease stage, biomarker status, prior therapy, line of therapy, ECOG assumptions, imaging availability, lab availability, outcomes, and exclusion-sensitive criteria.
- RWD source assessment framework for disease coverage, oncology depth, biomarker availability, treatment history, imaging, labs, follow-up, completeness, de-identification standards, and contracting requirements.
- Compliance and agreement check before any data-related work proceeds, including sponsor approval, provider availability, data use permissions, de-identification requirements, purpose limitation, downstream use restrictions, and cross-border restrictions.
- De-identified feasibility analysis where appropriate agreements and data access are in place.
What the deliverable answers
- 80-120 page data-backed strategy report covering RWD questions, cohort definition, feasibility logic, protocol risks, and site strategy.
- RWD feasibility framework with structured questions, required fields, source assessment criteria, and agreement-dependent analysis plan.
- Protocol risk redline identifying criteria that may reduce recruitment or require redesign.
- Site archetype strategy for academic centers, early phase units, community oncology networks, biomarker testing-capable sites, imaging-rich sites, and expansion cohort sites.
- Data-backed sponsor decision memo: proceed, redesign, broaden cohort, adjust eligibility, modify site strategy, re-brief CRO, or validate further.
- Sponsor readout with development recommendation and next-step discussion.
Compliance boundary
Use RWD only when it answers a concrete feasibility question.
This package is appropriate when the sponsor needs cohort feasibility and site strategy logic beyond public trial intelligence.
Agreement-dependent work
Any data-related work is subject to sponsor approval, data provider availability, appropriate agreements, and compliance review.
Three possible levels
Projects may stop at RWD planning, move to feasibility scoping, or proceed to data-backed strategy only when agreements and available de-identified outputs support it.