Differentiate your CNS offering with precision digital endpoints
Your sponsors need objective, quantitative endpoints for CNS trials. NeuroQuantix replaces subjective rating scales with 397 kinematic metrics from a 2-minute drawing task, integrates with your existing EDC infrastructure, and ships with the regulatory documentation your submissions team needs.
Why CROs choose NeuroQuantix
Operational specifics on how NeuroQuantix fits into your trial workflows.
Add Objective Motor Endpoints to CNS Proposals
When sponsors ask how you will measure treatment effects beyond UPDRS or TETRAS, NeuroQuantix gives you a concrete answer: 397 kinematic metrics from a 2-minute drawing task, backed by published effect sizes and a scoping review in Movement Disorders Clinical Practice.
Smaller Sample Sizes, Faster Enrollment
Published spiral metrics show Cohen's d = 3.96 for tremor severity and ICC = 0.97 for test-retest reliability. That translates to roughly 3x fewer subjects per arm at equivalent statistical power. For a CRO managing enrollment timelines, that is a material operational advantage.
21 CFR Part 11 and CDISC from Day One
Complete audit trails, electronic signatures, role-based access control, AES-256 encryption at rest, TLS 1.3 in transit. CDISC ODM exports feed directly into Medidata Rave, Oracle Clinical, or Veeva Vault. No data transformation layer needed.
Remove Rater Variability from Multi-Site Trials
Subjective rating scales require rater training, calibration sessions, and ongoing drift monitoring across sites. NeuroQuantix captures kinematic data automatically. The same 397 metrics are computed identically whether the patient is at Site 01 or Site 40.
Regulatory Submission Documentation Included
We provide endpoint narratives, validation summaries, and submission-ready data packages for FDA, EMA, PMDA, TGA, and Health Canada. Your regulatory affairs team receives documentation formatted for their existing submission workflows.
Under 30 Minutes from Unboxing to First Assessment
iPad Pro or Wacom digitizer deployment with standardized training materials. Clinical site coordinators administer the assessment without specialized technician support. We have deployed across academic medical centers, community sites, and decentralized trial settings.
The competitive advantage
vs. traditional clinical scales at equivalent power
From a single 2-minute drawing task
Published reliability for tremor metrics
FDA, EMA, PMDA, TGA, Health Canada
Fits your existing infrastructure
NeuroQuantix integrates with the EDC platforms, eCOA systems, and data management workflows your team already uses. CDISC-compliant exports flow directly into your existing regulatory submission pipeline.
Partnership Model
Strengthen your CNS capabilities
Schedule a partnership discussion to explore how NeuroQuantix integrates into your CNS clinical trial service offering.
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