Correlation & feasibility
Sensor-derived signals compared against gold-standard clinical measures to establish feasibility and relevance.
Digital biomarkers & endpoints
Digital biomarkers you can trust and defend.
From physiology to function, Delve turns raw wearable signals into validated, regulator-aligned digital measures, so sponsors can trust the data, defend the endpoint, and run it at scale across studies.
Protocol-alignedEndpoint definitions and outputs standardized
Real-timeQC for missingness, outliers, and device drift
AuditableTraceability from raw signal to endpoint
From raw signals to regulator-ready evidence.
Wearable data is noisy, inconsistent, and device-dependent. Digital biomarkers apply validated algorithms, statistical models, and context-aware transformations to turn it into clinical-grade measurements.
- Fit-for-purpose validation for clinical use
- Algorithm transparency and reproducibility
- Cross-device measurement equivalence
- Science-driven QC and accuracy checks
- End-to-end endpoint management
FDA · EMA · PMDAAligned with digital health technology frameworks
StandardDefinitions and QC rules across studies
VersionedOutputs traceable back to source data
Study-readyReporting built for oversight and submission
A three-phase validation framework.
A regulator-aligned, stepwise approach to turning raw sensor signals into defensible, submission-ready digital endpoints.
Algorithm training & calibration
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.
The digital biomarker library.
A broad, continuously expanding catalog. Each biomarker is validated for physiological accuracy, sampling reliability, and clinical interpretability.
Cardiovascular
Heart rate, HRV (RMSSD, SDNN), pulse morphology, and AFib risk indicators.
Respiratory
Respiratory rate, nocturnal RR trends, breath variability, and activity-adjusted burden.
Activity & function
Gait speed, step accuracy, 6MWT digital equivalent, and mobility signatures.
Sleep & circadian
Sleep stages, fragmentation index, circadian stability, and sleep efficiency.
Subjective plus objective makes a true digital endpoint.
The future of endpoints is hybrid. Delve fuses wearable signals with ePRO triggers, symptom diaries, and clinician assessments into composite endpoints with more explanatory power.
- Sensor-driven ePRO triggers and event-linked symptom capture
- Composite endpoints that blend function and perception
- Automated outlier detection
- Longitudinal trend modeling
Digital biomarkers in action.
The story behind every datapoint: the human experience inside the physiology.
Earlier toxicity signals
Real-time HRV and symptom correlation predicted early toxicity signals.
Earlier exacerbation detection
Nocturnal respiratory patterns improved early exacerbation detection.
Digital measures that match the clinic
Gait speed and 6MWT digital equivalents aligned with clinician assessments.
Go deeper.
How a signal becomes an endpoint, for teams evaluating digital biomarkers in depth.
From signal to endpoint: the pipeline
1. Signal
Raw signals ingested across devices and sampling rates.
2. QC
QC rules applied for missingness, artifacts, drift, and outliers.
3. Validation
Algorithms checked against the validation framework and context of use.
4. Endpoint
Endpoint output versioned, with traceability back to source data.
What regulator-ready means in practice
Delve helps sponsors deploy, validate, and scale digital biomarkers aligned with FDA, EMA, and PMDA digital health technology frameworks.
Standard definitions
Endpoint definitions aligned to the protocol and applied consistently across studies.
QC rules
Real-time checks for missingness, outliers, and device drift.
Versioned outputs
Every endpoint output traceable from raw signal to result.
Study-ready reporting
Definitions, traceability, and reporting ready for oversight and review.
From the Knowledge Hub
Endpoint design, signal quality, and therapeutic-area applications for digital biomarkers.
eCOA vs ePRO vs DHT
How these three categories differ, and why modern trials need all of them working together.
Read →Signal Quality Control for Wearable Data
How signal QC protects endpoint integrity before, during, and after data lock.
Read →Cardiology Digital Endpoints Between Visits
Continuous cardiac signal capture and the endpoints it makes possible.
Read →Digital Endpoints in CNS Trials
How wearables and digital measures change the data picture in CNS studies between visits.
Read →Explore Delve’s digital biomarker portfolio.
See how validated digital endpoints can accelerate your next study.
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