Is the trial design suitable for the U.S. market?
Review indication fit, endpoint logic, eligibility burden, biomarker requirements, and whether the U.S. evidence story is credible before execution begins.
Why before CRO
Why not just hand the plan to a CRO?
Because the CRO will execute the plan. Whether the plan itself holds up is a sponsor-side judgment. OncoLattice does not replace the CRO; we help sponsors ask the hard questions before budget is committed.
CROs are essential execution partners.
A sponsor-side decision gate before execution spend.
They are built to run trials: site startup, project management, monitoring, data management, and clinical operations. But before execution, China-based oncology sponsors need a strategy layer that tests whether the plan itself is ready for U.S. FIH or Phase 1 execution.
Is the patient population realistically recruitable?
Pressure-test cohort size, competing studies, diagnostic pathways, and the practical availability of the target population.
Does the protocol need to be redesigned first?
Identify design elements that may create avoidable activation delay, screen-failure burden, or site reluctance.
Should site strategy be based on execution fit instead of prestige?
Compare patient distribution, mechanism experience, biomarker capability, PI load, and regional concentration risk.
Can the sponsor independently evaluate the CRO proposal?
Enter CRO discussions with a challenge memo, site-list questions, and clear criteria for accepting or revising the plan.
Why before CRO
CRO vs OncoLattice
The distinction is not whether a sponsor needs a CRO. The distinction is when the sponsor should enter CRO execution and with what level of preparation.
CROOncoLattice Bio
Primary roleExecution planPre-execution decision intelligence
OperationsSite startup, monitoring, data managementProtocol risk, cohort feasibility, and site archetype strategy
Feasibility lensOperational feasibility for an execution planWhether the plan should be executed, redesigned, or paused
Sponsor controlBudget, timeline, and operational planCRO brief and proposal review logic
OutputOperating plan and execution budgetGo / Redesign / No-Go memo
Enter CRO discussions with a stronger sponsor-side position.
The goal is not to delay execution. The goal is to prevent premature execution of a trial design, cohort assumption, or site strategy that has not been tested carefully enough.