Therapeutic Development

Clinical Trials

Enable faster, more sensitive detection of treatment effects with objective cognitive endpoints that correlate with clinical meaningful change.

What You Get

Concrete deliverables and measurements tailored to your environment

1

Objective Primary & Secondary Endpoints

Multimodal cognitive endpoints that detect treatment-related cognitive change with high sensitivity and specificity.

2

Reduced Sample Size & Timeline

Continuous measurement captures treatment signal earlier, potentially reducing enrollment needs and study duration.

3

Real-Time Data Quality

Automated data collection and validation minimize missing data, protocol deviations, and site variability.

4

Regulatory-Grade Documentation

Audit trails, electronic consent, and comprehensive safety monitoring support FDA submissions and post-market surveillance.

Validation & Evidence

Rigorous methodology and peer-reviewed research supporting this approach

Sensitivity to Treatment Effects

Published data demonstrates cognitive endpoints detect meaningful treatment response in Alzheimer's, depression, and autism studies.

FDA Digital Health Alignment

Measurement approach aligns with FDA guidance on digital health technologies, clinical outcome assessment, and remote monitoring.

Regulatory Precedent

Acceptance of multimodal cognitive assessment in clinical trials across Phase II, III, and post-market surveillance studies.

Cost-Effectiveness

Reduced site burden and remote monitoring capability lower operational costs per subject enrolled.

Typical Use Cases

Cognitive endpoints in Alzheimer's disease trials

Depression and treatment-resistant depression studies

Autism spectrum disorder intervention trials

Parkinson's disease and movement disorder assessments

ADHD medication efficacy and long-term monitoring

Neurodevelopmental disorder therapeutic trials

Ready to integrate into your clinical trials?

Discuss a Deployment