The evidence your biostatistician will ask for

One document, written for the people who have to defend an endpoint choice: what is measured, what has been published, what is still being validated, and how the endpoint is pre-specified so it survives a Type C meeting.

• A fit-for-purpose endpoint: how one kinematic metric is specified a priori for the indication and mechanism
• Published evidence mapped to the implemented metrics, with citations, from an evidence database of 200+ studies standardized from our scoping review
• Sample size: the cited reliability figures for the rating scale and the kinematic metric, and what they mean for subjects per arm
• The standardized administration protocol: practice-effect control, instruction scripting, run-in baseline, a-priori metric selection
• Regulatory positioning: the FDA clinical outcome assessment framework and the sponsor COA dossier
• Compliance and data flow: 21 CFR Part 11, EU GMP Annex 11, GxP, HIPAA, CDISC; EDC and eCOA integration; site training in under 30 minutes
• How an engagement starts: briefing, written pilot scope, exploratory endpoint in your next study

NeuroQuantix delivers a fit-for-purpose kinematic endpoint: one metric, specified a priori for the indication and the mechanism of action, with the concept of interest, context of use, and supporting evidence documented in the form the FDA clinical outcome assessment framework describes. A standardized administration protocol that controls practice effects and rater dependence and preserves sensitivity to treatment effects.