Non-confidential context intake
We begin with the asset stage, target, MOA, indication, proposed patient population, current protocol concept, U.S. development objective, and the team's main execution concerns.
Workflow / Pre-CRO pathway review
Do not wait until CRO startup to find the problem.
Before budget, timelines, and first-wave site lists become hard to change, we break down the patient, protocol, site, and CRO assumptions to see what can proceed, what deserves challenge, and what should change first.
Workflow / Pre-CRO pathway review
The work usually moves in this order.
This is not a decorative process diagram. It is a way to ask the questions that often get skipped before CRO meetings and execution budgets harden.
Protocol assumption breakdown
We break the synopsis into testable assumptions: cancer type, biomarker requirements, prior therapy, line of therapy, disease stage, inclusion criteria, exclusion criteria, and endpoint logic.
Patient and competition pressure review
We review whether the target cohort may be too narrow, where screening risk may appear, how crowded the indication or mechanism is, and which questions should be challenged before a CRO meeting.
Site archetype and PI load review
Using public trial footprints, indication experience, mechanism fit, early-phase capability, and potential investigator load, we review whether the first-wave site archetypes are reasonable.
CRO challenge-question list
We convert patient, site, timeline, screening, testing, and competition risks into questions the sponsor can bring directly into CRO proposal or kickoff discussions.
Go / redesign / pause judgment
We organize the review into sponsor-facing judgments: what can proceed, what should be redesigned, and what deserves more validation before more budget is committed.
Sponsor decision memo
We deliver leadership-ready material for internal review, CRO briefing, board updates, or BD / investor diligence before confidential details are shared more broadly.
Questions that change the plan
The questions that usually change the plan
Not every question requires a large engagement. But the later these questions surface, the more they become timeline, budget, and leadership-explanation problems.
Can the patients be found?
Is the target cohort too narrow, and might inclusion or exclusion criteria materially reduce recruitability?
Are first-wave sites reasonable?
Are sites being chosen for reputation alone, or do they match mechanism, testing, early-phase capability, and patient source?
Are key PIs overloaded?
Are prestige investigators already carrying too many similar trials, and should alternate or supplemental investigators be considered?
Do CRO assumptions hold?
Are timeline, screen-failure, startup, testing, and enrollment assumptions supported by the available evidence?
Does the U.S. story hold together?
Do the patient, protocol, site, and later global development narratives fit into one defensible strategy?
When should the plan change?
Which signals suggest redesigning protocol, site mix, or patient strategy before moving into execution?
How to start
Not sure where to start?
Formal projects use sponsor-approved materials under appropriate CDA/NDA and governance. During an introductory discussion, please share only non-confidential context.
Start with non-confidential context in a 30-minute discussion. We will help determine whether the immediate issue is patient logic, site strategy, CRO proposal review, or leadership material.