Traditional clinical endpoints require in-clinic visits. Digital biomarkers (gait, sleep, heart rate variability, voice analysis) are captured continuously but lack standardized collection and analysis. FDA is accepting digital endpoints but requires validated measurement. Pharma spends $50K+ per patient in clinical trials for in-person assessments. No standardized platform exists for digital biomarker collection and analysis.
Digital biomarker platform that collects sensor data from smartphones and wearables, applies validated algorithms to extract clinical biomarkers, provides regulatory-grade evidence packages, and integrates with clinical trial management systems.
Pharmaceutical companies running decentralized clinical trials, digital therapeutics companies needing outcome validation, and academic researchers studying digital health endpoints
FDA Digital Health Center of Excellence is accepting digital endpoints. Decentralized trials demand remote measurement. Smartphone sensors are clinical-grade. Pharma R&D budgets are shifting to digital. Wearable data volume is exploding.
Per-subject: $50–$200/subject/month based on biomarkers collected. Platform: $4,999/mo (single trial, up to 100 subjects), $9,999/mo (multiple trials). SDK licensing: $25K–$100K annual license fee.
$500K+ per trial, 12+ months development, not reusable across studies
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