A focused readiness assessment before U.S. FIH / Phase 1 execution.

Service detail

The decision it helps you make

A sponsor may not need a full CRO execution plan yet. The immediate question is whether the U.S. early clinical path is coherent enough to move toward execution or whether key assumptions should be redesigned first.

What you share, what we review

• Asset quick review: target, mechanism of action, modality, proposed indication, target population, current stage, available data, and U.S. development objective.
• Comparable U.S. oncology trial scan by target, indication, modality, phase, sponsor type, recruitment status, endpoint pattern, site count, and eligibility criteria.
• Initial protocol risk signals such as narrow inclusion criteria, restrictive exclusions, biomarker bottlenecks, line-of-therapy assumptions, and endpoint mismatches.
• Early patient feasibility risk screen to judge whether deeper expert review or RWD feasibility planning may be needed.

What the deliverable answers

• 15-25 page sponsor-facing diagnostic memo summarizing landscape, risk signals, and readiness conclusion.
• Comparable U.S. trial landscape scan and initial competitor / indication risk assessment.
• Protocol, patient feasibility, indication, and competitive risk flags.
• Clear Go, Redesign, Not Ready, or Need More Validation recommendation.
• One 60-minute readout call to discuss findings and next steps.