Objective endpoints. Smaller trials.
NeuroQuantix delivers regulatory-grade digital endpoints for CNS clinical trials from a brief drawing assessment. Published effect sizes on digitized spiral analysis enable sample size reductions of 60% or more vs. traditional rating scales, with a clear FDA COA/DDT qualification pathway.
Standardizes 44 years of published spiral analysis research into a single endpoint platform. Scoping review of 120 studies in Movement Disorders Clinical Practice.
Objective digital endpoints for global CNS programs
Designed as a Clinical Outcome Assessment and Drug Development Tool for regulatory submissions to FDA, EMA, PMDA, TGA, and Health Canada. NeuroQuantix provides the objective, quantitative motor endpoints across 23 neurological conditions that clinical trials demand and regulators increasingly expect.
Registration Trial Endpoints
Pre-specified primary or secondary endpoints for Phase 2/3 efficacy trials. Published effect sizes enable powered studies with fewer subjects across ET, PD, dystonia, and ataxia indications.
Phase 1-2 De-Risking
Exploratory digital endpoints in early-phase trials to establish dose-response signal and de-risk your Phase 3 endpoint strategy before committing enrollment resources.
Gene Therapy & Rare Disease
Published effect sizes (d = 1.4-3.96) enable powered studies with as few as 6-9 subjects per arm. Designed for populations where traditional scales require more patients than are available.
Drug Safety Monitoring
Quantify drug-induced movement disorders as adverse event signals in CNS pharmacovigilance. Detect subtle motor changes before they reach clinical thresholds on subjective scales.
Natural History Studies
Establish endpoint performance and disease trajectory data to support a future IND. High test-retest reliability (ICC 0.89-0.97) enables longitudinal tracking of motor change over time.
Neuromodulation Outcomes
Objective motor assessment for DBS programming optimization and outcome studies. Published validation shows discrimination of stimulation on vs. off states.
What sets this platform apart
Not another wearable or black-box algorithm. NeuroQuantix is a deterministic, literature-grounded clinical measurement system built for regulatory scrutiny.
Pre-Specified, Defensible Endpoints
NeuroQuantix draws from a deep kinematic library across 12 measurement domains to deliver a pre-specified endpoint for your specific indication. Not a fishing expedition; a targeted, defensible selection backed by published evidence.
Transparent, Auditable Rules
Every diagnostic rule is grounded in peer-reviewed literature with full citation provenance. Every threshold is documented and auditable. Designed to withstand regulatory scrutiny in a Type C meeting.
3D Hand Dynamics
Captures pen tilt tremor through stylus altitude and azimuth, a dimension most digital platforms miss entirely. Published literature shows AUC of 0.933 for PD detection via tilt-pressure analysis.
Frequency-Based Differential
Decomposes tremor across frequency bands (3-7 Hz parkinsonian, 7-12 Hz essential, 12-25 Hz orthostatic/myoclonic) for objective differential characterization that subjective scales cannot provide.
iPad-Based, Minimal Site Burden
Brief drawing assessment on iPad Pro. No specialized technician required. Minimal site training. Designed for multi-site global trials where site burden determines compliance.
44 Years of Published Evidence
NeuroQuantix standardizes and operationalizes the published literature on digitized spiral analysis. Our scoping review of 120 studies maps the evidence base and the gaps the platform addresses.
Built for regulated environments
Designed from the ground up for clinical trial deployment in GxP-regulated environments with the compliance infrastructure pharma sponsors require.
21 CFR Part 11
Electronic records with complete audit trails, access controls, and electronic signature capability for FDA-regulated trials.
HIPAA Compliant
Data encryption at rest and in transit, role-based access control, and de-identification protocols for protected health information.
COA / DDT Pathway
Designed for FDA Clinical Outcome Assessment and Drug Development Tool qualification as a primary or secondary endpoint.
GxP Compatible
Validated for clinical trial environments with CDISC-compliant data exports, EDC integration, and regulatory submission-ready outputs.
Fewer subjects. Faster trials.
Higher measurement sensitivity translates directly to smaller enrollment requirements. Published data shows digital spiral metrics require up to 3x fewer subjects per arm to achieve the same statistical power.
Subjective scales cost CNS trials years and hundreds of millions
A trained rater observing a spiral drawing task produces one subjective score on an ordinal scale. Sampled once, prone to inter-rater variability, and constrained by ceiling and floor effects. Published literature demonstrates that digital spiral analysis captures the same task with continuous, high-resolution measurement across tremor, velocity, pressure, and motor control domains.
NeuroQuantix synthesizes this measurement depth into a pre-specified endpoint for your specific indication. The platform draws from 12 kinematic domains to select the metric profile most sensitive to your treatment mechanism, then locks it into a defensible analysis plan. The result is a single, approvable framework that withstands regulatory scrutiny.
Review the Technical Data12 Kinematic Domains
De-risk your endpoint strategy from Phase 1 through submission
NeuroQuantix is led by a clinical trial subject matter expert with deep experience across CNS drug development. Our products and consulting services work together to de-risk your endpoint strategy from Phase 1 through regulatory submission.
The endpoint decision you make in Phase 1 determines your Phase 3 outcome
Programs that defer endpoint strategy to later phases routinely discover their instruments lack the sensitivity to detect treatment effects, after investing years and tens of millions. Correcting course mid-program means new validation studies, regulatory renegotiation, and enrollment delays.
We engage at Phase 1 because the cost of getting endpoint strategy right from the start is a fraction of the cost of getting it wrong at Phase 3. For gene therapy programs with small, rare-disease populations, this is the difference between a successful submission and a clinical hold.
Built for teams running global CNS programs
Pharmaceutical & Biotech
Running CNS trials where subjective clinical scales introduce variability that obscures your treatment effect? We provide objective digital endpoints and expert consulting to solve that problem directly.
Gene Therapy Companies
Traditional scales cannot power a 20-subject trial. Published literature on digitized spiral analysis demonstrates effect sizes (d = 1.4 to 3.96) that enable powered studies with up to 3x fewer subjects per arm. Built for the populations where every enrollment slot counts.
Contract Research Organizations
Differentiate your CNS offering with precision measurement expertise, central rater committees, and validated digital endpoints your sponsor clients demand.
Academic Medical Centers
Objective, quantitative motor endpoints for investigator-initiated trials. Validated metrics that strengthen grant applications and publication impact.
Experience that compounds
Led by a clinical trial subject matter expert with direct experience across 40+ CNS clinical programs worldwide.
Across movement disorders, neurodegenerative disease, psychiatry, and rare conditions
Scoping review published in Movement Disorders Clinical Practice (Wiley)
FDA, EMA, PMDA, TGA, and Health Canada program experience
Key Opinion Leaders across neurology, movement disorders, and CNS development
FaceWise Memory Consolidation
An AI-administered name-to-face free recall assessment that measures sleep-dependent memory consolidation. Built on the FNAME paradigm validated in the NIH Toolbox. Standard cognitive batteries use 30-minute recall delays and miss consolidation entirely. FaceWise captures what happens overnight.
No other assessment in the decentralized trial space measures this domain. Targets subjective memory complaint through moderate Alzheimer's disease, the populations where consolidation deficits appear earliest and existing instruments lack sensitivity.
Learn More About FaceWiseDo not let insensitive endpoints sink your CNS program
From essential tremor and Parkinson disease to gene therapy trials and rare neurodegenerative conditions, we bring precision measurement and expert consulting to programs worldwide.
Request a scientific brief, schedule a consultation, or discuss how NeuroQuantix integrates into your trial design. We respond within 24 hours.