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Strengthen the trial before time and capital are committed.
An independent, cross-functional evaluation of whether a clinical trial can answer the right question, support the intended label, and be executed successfully.
The problem
A protocol may appear scientifically sound while remaining vulnerable to the wrong population, comparator, endpoints, estimand, power assumptions, operational burden, regulatory expectations, safety monitoring, or manufacturing readiness. Those weaknesses become expensive once enrollment begins.
The HEOS solution
HEOS evaluates the trial backward from the desired clinical and regulatory outcome and forward from the evidence already available—connecting clinical, statistical, regulatory, safety, operational, quality, manufacturing, patient, and commercial perspectives.
How we do it
Senior experts work from assessment through execution, with clear decisions, accountable actions, and measurable outcomes.
Clarify the target patient, clinical use case, target label, value proposition, decision criteria, and evidence the trial must generate.
Evaluate eligibility, comparator, endpoints, estimands, statistics, duration, safety monitoring, operational feasibility, supply assumptions, and regulatory acceptability.
Prioritize design changes, evidence needs, agency questions, operational mitigations, decision gates, and the strongest feasible development strategy.
What you get
How success is measured
The finish line
Cross-functional expertise. Better decisions.
Tell us what you are evaluating, building, or preparing to execute. HEOS will assemble the right expertise around the work.