Endpoint readiness

Protocol-aligned

Definitions + outputs standardized

Quality controls

Real-time

Missingness, outliers, device drift

Traceability

Auditable

From raw signal → endpoint

Validated digital measures for clinical development

Wearables • Digital Biomarkers • Endpoints

Digital Biomarkers & Endpoints
Powered by Real-World Data.

From physiology to function, Delve transforms raw wearable signals into validated, regulator-aligned digital measures—so sponsors can trust the data, defend the endpoint, and operationalize it at scale across studies.

Explore the Endpoint Library Request a Walkthrough

Standard definitions · QC rules · Versioned outputs · Study-ready reporting.

RAW

MODEL

Endpoint Pipeline

Signal → QC → Validation → Endpoint

Raw signals ingested across devices and sampling rates.

QC rules apply: missingness, artifacts, drift, and outlier detection.

Endpoint output versioned with traceability back to source data.

Regulator-ready Definitions + traceability + reporting

From Raw Signals to Regulator-Ready Evidence

Wearable data is noisy, inconsistent, and device-dependent. Digital biomarkers solve this by applying validated algorithms, statistical models, and context-aware transformations that turn continuous sensor data into meaningful, clinical-grade measurements.

Delve enables sponsors to rapidly deploy, validate, and scale digital biomarkers aligned with FDA, EMA, and PMDA digital health technology frameworks.

Fit-for-purpose validation for clinical use
Algorithm transparency & reproducibility
Cross-device measurement equivalence
Science-driven QC & accuracy checks
End-to-end endpoint management

Our 3-Phase Digital Endpoint Validation Framework

1. Correlation & Feasibility

Compare sensor-derived signals against gold-standard clinical tools to confirm feasibility.

2. Algorithm Training & Calibration

Generate reproducible, device-agnostic algorithms with consistent sampling and signal quality.

3. Verification & Submission Readiness

Measurement accuracy, variance, reproducibility, and context-of-use verification for FDA/EMA review.

Digital Biomarker Library

Delve supports a broad and continuously expanding catalog of digital biomarkers. Each is validated for physiological accuracy, sampling reliability, and clinical interpretability.

Cardiovascular

Heart Rate
HR Variability (RMSSD, SDNN)
Pulse Morphology
AFib Risk Indicators

Respiratory

Respiratory Rate
Nocturnal RR Trends
Breath Variability
Activity-adjusted Respiratory Burden

Activity & Function

Gait Speed
Step Count Accuracy
6MWT Digital Equivalent
Functional Mobility Signatures

Sleep & Circadian

Sleep Stages
Fragmentation Index
Circadian Rhythm Stability
Sleep Efficiency

Subjective + Objective = True Digital Endpoints

The future of endpoints is hybrid. Delve fuses wearable signals with ePRO triggers, symptom diaries, and clinician assessments to produce composite endpoints with richer explanatory power.

Sensor-driven ePRO triggers
Event-linked symptom capture
Composite endpoints blending function + perception
Automated outlier detection
Longitudinal trend modeling

This is how Delve reveals the story behind every datapoint — the human experience inside the physiology.

Digital Biomarkers in Action

Cardio-Oncology Study

Real-time HRV + symptom correlation predicted early toxicity signals.

Respiratory Trial

Nocturnal respiratory patterns improved early exacerbation detection.

Mobility Study

Gait speed and 6MWT digital equivalents aligned with clinician assessments.

Digital Biomarkers & Endpoints Powered by Real-World Data.