Digital Biomarkers & Endpoints | Delve Health

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

Digital Biomarkers & Endpoints
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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
QC
MODEL
EP

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
Digital biomarker overview

Our 3-Phase Digital Endpoint Validation Framework

A regulator-aligned, stepwise approach to transforming raw sensor signals into defensible, submission-ready digital endpoints.

Correlation & Feasibility

Compare sensor-derived signals against gold-standard clinical measures to establish feasibility and relevance.

Algorithm Training & Calibration

Build reproducible, device-agnostic algorithms with controlled sampling, normalization, and signal quality checks.

Verification & Submission Readiness

Accuracy, variance, reproducibility, and context-of-use validation aligned to FDA and EMA expectations.

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 HRV (RMSSD, SDNN) Pulse Morphology AFib Risk Indicators

Respiratory

Respiratory Rate Nocturnal RR Trends Breath Variability Activity-Adjusted Burden

Activity & Function

Gait Speed Step Accuracy 6MWT Digital Equivalent Mobility Signatures

Sleep & Circadian

Sleep Stages Fragmentation Index Circadian 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.

Wearables + eCOA fusion

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.

Explore Delve’s Digital Biomarker Portfolio

See how validated digital endpoints can accelerate your next study.

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