Differentiate your CNS offering with precision digital endpoints
Your sponsors need objective, quantitative endpoints for CNS trials. NeuroQuantix delivers objective, pre-specified digital endpoints from a brief drawing assessment, 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 want to add objective digital endpoints alongside traditional clinician-rated scales like UPDRS or TETRAS, NeuroQuantix gives you a concrete answer: objective, pre-specified endpoints backed by substantial published evidence and a scoping review of 120 studies in Movement Disorders Clinical Practice.
Smaller Cohorts, Faster Enrollment
Continuous, high-frequency kinematic measurement provides substantially higher sensitivity than ordinal rating scales — meaning powered studies with smaller cohorts 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 objective measurements 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, 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
Across 12 measurement domains, each mapped to published literature
Differential profiles across movement disorders, neurodegenerative, demyelinating
Peer-reviewed evidence underlying the platform
FDA, EMA, 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
Explore our capabilities
FaceWise
Memory consolidation endpoints for cognitive decline trials in the decentralized setting.
Central Rater Committees
Rater calibration and adjudication infrastructure for multi-site CNS programs.
Endpoint Consulting
Strategic endpoint selection across traditional and digital COAs.
21 CFR Part 11 Compliance
Regulatory-grade data infrastructure with audit trails, CDISC exports, and GxP compatibility.
Regulatory Strategy
Global regulatory navigation across FDA, EMA, and Health Canada.
Published Research
Scoping review in Movement Disorders Clinical Practice and effect size data.
Frequently Asked Questions
How can CROs differentiate their CNS offering with digital endpoints?
CROs can offer sponsors objective, quantitative motor endpoints that reduce rater variability, enable powered studies with smaller cohorts, and provide 21 CFR Part 11 and Annex 11-compliant data with CDISC exports. NeuroQuantix integrates with existing EDC platforms and deploys at clinical sites in under 30 minutes.
What does the CRO partnership model look like?
We configure NeuroQuantix for your trial protocols and EDC setup, provide standardized site training, deliver real-time data quality monitoring, and supply regulatory documentation including endpoint narratives and submission-ready data packages.
How does NeuroQuantix reduce operational complexity for multi-site trials?
NeuroQuantix captures kinematic data automatically, producing identical metrics across all sites. This removes rater variability as an operational risk and reduces the need for central rater infrastructure on subjective motor scales.
What training is required for clinical site staff to use NeuroQuantix?
Clinical site coordinators can administer assessments without specialized technician support. The platform deploys on iPad Pro or Wacom digitizer with standardized training materials. Total setup time from unboxing to first assessment is under 30 minutes.
Does NeuroQuantix support decentralized clinical trials?
Yes. NeuroQuantix supports tablet-based assessment in decentralized and hybrid trial designs. Data is captured identically whether at a traditional site, community site, or home setting. All data flows through 21 CFR Part 11-compliant infrastructure.
What data formats does NeuroQuantix export for CRO data management?
CDISC ODM format with SDTM-compatible data structures. Exports integrate directly with Medidata Rave, Oracle Clinical, Veeva Vault, and other EDC platforms. Raw kinematic data and computed metrics are both available.
Strengthen your CNS capabilities
Schedule a partnership discussion to explore how NeuroQuantix integrates into your CNS clinical trial service offering.
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