Not a CRO or clinical operations team
FIH Scout Plus is a sponsor-side strategy and review package. It does not execute the trial, activate sites, monitor studies, or manage clinical data.
FIH Scout Plus
Sponsor-side U.S. FIH / Phase 1 strategy before CRO execution.
FIH Scout Plus helps sponsors evaluate trial design, patient feasibility, site archetype strategy, and CRO briefing logic before committing major execution budgets.
Service detail
The decision it helps you make
The sponsor will likely still need a CRO. The key question is whether the U.S. FIH or Phase 1 strategy makes sense before the sponsor asks a CRO to execute it.
What you share, what we review
- Deep asset intake covering target, modality, indication, disease stage, biomarker strategy, patient population, line of therapy, protocol concept, and current CRO discussions.
- FIH Scout trial landscape analysis by comparable U.S. oncology trials, dose escalation design, expansion cohorts, endpoints, enrollment, trial status, site count, and competitive intensity.
- Protocol pattern analysis across inclusion, exclusion, biomarkers, prior therapy, ECOG, CNS metastases, organ function, endpoints, and dose design.
- Patient feasibility risk map for cohort narrowness, biomarker constraints, prior therapy realism, and competing trial pressure.
- Site archetype strategy and CRO briefing questions that help the sponsor challenge site selection, recruitment, screen failure, and timeline assumptions.
What the deliverable answers
- 50-80 page strategy report covering trial landscape, protocol patterns, patient feasibility risks, site archetypes, and decisions.
- 10-page leadership-ready executive deck for CEO, CMO, board, investor, or BD discussions.
- CRO briefing questions to test patient availability, site evidence, biomarker testing availability, screen failure assumptions, and competing trial pressure.
- Independent expert review where appropriate for oncology development, regulatory, or operational assumptions.
- Sponsor decision memo: Go, Redesign, No-Go, Need RWD Validation, or Need Expert / Regulatory Review.
- Two strategy calls: kickoff / working discussion and final readout.
What is not included
Pressure-test the strategy before CRO execution starts.
Use FIH Scout Plus when the sponsor needs an independent decision layer between clinical ambition and CRO execution.
No enrollment guarantee
We identify patient feasibility, site archetype, and peer-trial pressure, but do not guarantee patient counts, screen success, or enrollment speed.
No real hospital ranking claim
Outputs are anonymized diligence priorities, risk flags, and question lists unless otherwise authorized. We do not imply private hospital relationships or data access.