Already have a CRO? Use FIH Scout and RWD feasibility logic to move faster.

Service detail

The problem it solves

Once CRO startup begins, the expensive mistake is not asking too many questions. It is continuing with the wrong sites, wrong regions, or overly optimistic patient assumptions. We help sponsors break the CRO plan into testable execution assumptions: which sites to prioritize, which patient sources matter most, and which screening or testing bottlenecks should be addressed before momentum builds in the wrong direction.

What you share, what we review

• Current CRO materials: first-wave site list, feasibility summary, startup timeline, budget assumptions, enrollment assumptions, screening flow, and key operational questions.
• FIH Scout site and PI signals: early-phase oncology experience, mechanism fit, PI workload, similar trial participation, competitive trial density, and regional concentration risk.
• Patient distribution and source assumptions: cancer type, line of therapy, biomarker status, testing pathway, prior treatment pattern, referral route, and whether current sites match likely patient sources.
• CRO plan pressure test: screen-failure assumptions, testing capacity, activation timing, first-wave site logic, expansion cadence, and whether patient competition should reorder priorities.
• RWD feasibility question design where appropriate: de-identified data outputs or third-party data costs are discussed only when sponsor authorization, provider availability, and agreements support that work.

What the deliverable answers

• CRO acceleration memo identifying which sites, regions, or patient sources should be prioritized, challenged, delayed, or re-diligenced.
• Site priority and challenge list translating FIH Scout signals into CRO weekly-meeting or startup-meeting questions.
• Patient distribution assumption review showing whether the current site mix matches target patient sources, testing capacity, and competitive pressure.
• CRO plan risk flags around screen failure, slow startup, PI overload, biomarker bottlenecks, or regional concentration.
• Next-action tracker listing what the CRO should provide, what sites should confirm, and what the sponsor should decide internally.
• One readout call to prepare sponsor-side or CRO-facing discussion.