Endpoint Consulting
Strategic endpoint selection and development for CNS clinical trials. The measurement decisions made in early development define the sensitivity and regulatory acceptance of every subsequent trial.
Endpoint strategy is the invisible architecture of a clinical program. The endpoints chosen in Phase 1 and Phase 2 determine whether Phase 3 will have the sensitivity to detect real treatment effects. They determine whether regulatory reviewers will accept the evidence of efficacy. And they determine whether the investment of years and hundreds of millions of dollars will produce an approvable product.
We specialize in the CNS therapeutic space where endpoint selection is particularly challenging. Neurological and psychiatric conditions present with heterogeneous symptom profiles, subjective assessment tools with limited sensitivity, and a regulatory landscape that is actively evolving as digital endpoints gain acceptance.
Our approach starts with the clinical question your therapeutic is designed to answer, works backward through the regulatory requirements for your target indication, and arrives at a measurement strategy that is both scientifically valid and regulatorily defensible. We engage at the earliest stages of development because the cost of correcting an endpoint strategy mid-program is measured in years and tens of millions of dollars.
What We Deliver
Endpoint Selection Strategy
Identification and evaluation of primary, secondary, and exploratory endpoints aligned with your therapeutic mechanism and regulatory path.
Assessment Tool Evaluation
Critical analysis of existing rating scales, digital biomarkers, and performance-based measures for your target indication and population.
Digital Endpoint Integration
Strategy for incorporating digital and technology-based endpoints alongside traditional clinical outcome assessments.
Regulatory Alignment
Ensure endpoint strategy aligns with FDA guidance, EMA expectations, and precedent from successful programs in your therapeutic area.
Statistical Sensitivity Analysis
Power analysis and effect size modeling to ensure selected endpoints can detect clinically meaningful treatment effects at planned sample sizes.
Longitudinal Endpoint Design
Design measurement strategies that capture treatment effects across the full trial duration, including responder analyses and time-to-event frameworks.
Typical Deliverables
Get your endpoint strategy right from the start
Whether you are in preclinical planning or mid-program course correction, we can help you build an endpoint strategy that stands up to regulatory scrutiny.
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