Usable data

↑

With harmonized pipelines

Device onboarding

Fast

BYOD or provisioned + SIM

Signal to insight

Near-real-time

QC + alerts + workflows

Digital measures built for clinical trials

Digital Measures for Clinical Trials Powered by Wearables

Transform raw sensor signals into standardized, endpoint-ready measures. Harmonize every device, operationalize every workflow, and generate continuous evidence—backed by human support that protects compliance and data quality.

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ECG

SpO₂

ACT

Digital Measures Pipeline

Device → QC → Harmonize → Endpoint

Ingest: multi-device streams (wearables + sensors)

QC rules: detect gaps, sync failures, and outliers in near-real time

Endpoint-ready outputs: standardized metrics aligned to protocol definitions

Compliance protected Human outreach when devices fail or tasks slip

From Sensors to Submissions

Sponsors don’t just need wearables—they need digital measures designed for accuracy, reproducibility, and clinical relevance.

Delve converts multi-device signals into standardized metrics and validated digital endpoints, aligned to study definitions and operational reality across hybrid and decentralized trials.

Fit-for-purpose digital endpoint development
Correlation to gold standards
Algorithm training & verification pathways
Regulatory-aligned study documentation & traceability

Wearable Modalities Supported

Fit-for-purpose device strategies aligned to endpoint sensitivity, patient burden, and operational feasibility.

Activity & Mobility

Steps, gait proxies, activity tolerance, functional change.

Cardiovascular

HR, HRV, ECG (device-dependent), blood pressure.

Respiratory

SpO₂, respiratory rate, symptom-linked physiology.

Sleep

Duration, efficiency, staging where supported.

Metabolic

CGM, weight scales, longitudinal trend analysis.

Temperature & Vitals

Skin temperature and longitudinal vital trends.

Device Integration & Signal Harmonization

Connect any wearable or sensor, harmonize signals into a consistent clinical model, and keep data clean with automated QC.

Universal Device Compatibility

Connect medical wearables, consumer sensors, cellular devices, or BYOD—all in one platform.

Real-Time Signal Harmonization

Normalize HR, HRV, SpO₂, sleep, steps, and respiratory data into a consistent clinical data model.

Automated QC & Signal Integrity

Detect outliers, missing samples, device drift, timestamp errors, and physiological anomalies.

Open Endpoint APIs

Export harmonized endpoints directly to EDC, analytics pipelines, or regulatory submission packages.

40+

Countries Supported

95%

Device Uptime

3,500+

Devices Provisioned

Digital Endpoint R&D Pipeline

Delve is building a defensible pipeline for digital endpoints and AI-enabled study operations—focused on making sensor data submission-grade and operationally reliable in the real world.

Stage 1: Device ingestion + telemetry + QC (in production)
Stage 2: Signal harmonization and measures library (in production / expanding)
Stage 3: Endpoint validation packs (active: gold-standard correlation + reproducibility)
Stage 4: AI-assisted protocol mapping & risk flags (active)
Stage 5: Post-market and real-world evidence workflows (roadmap)

This approach supports cardiovascular, oncology, metabolic, respiratory, and chronic disease programs— and extends evidence generation across the full lifecycle.

The Wearables Reality No One Talks About

Digital measures fail not because the sensors fail— but because no one operationalizes the devices.

Patients forget to charge devices. Sites are overwhelmed. CROs lack playbooks. Data gaps grow quietly.

Delve steps in with automation + real human follow-up so every wearable actually works in the real world.

Missed sync detection & human outreach
Battery, connectivity & signal monitoring
Device troubleshooting & onboarding
Site workflows & escalation paths
Global multilingual support

Digital Endpoints & Real-Time Clinical Insights

Transform raw sensor data into validated digital endpoints with live visibility into patient status, signal quality, and clinical trends.

Validated Algorithms

Gait speed, step quality, HR/HRV, sleep staging, SpO₂ trends, respiratory rate, and more.

Regulatory-Ready Digital Endpoints

Developed using correlation, training, verification, and FDA-aligned methodologies.

Live Endpoint Dashboards

Monitor patient status, signal stability, algorithm outputs, and longitudinal trends.

Endpoint + ePRO Fusion

Combine symptoms, diaries, and objective measures into unified digital outcomes.

Validated Algorithm Library

70+ validated algorithms across six modalities

Delve's algorithm library converts raw wearable and digital health signals into validated, audit-grade endpoints. Every algorithm is documented, version-controlled, and aligned with FDA Digital Health Technology guidance, the Digital Medicine Society's V3 validation framework, and ICH E6(R3) data integrity expectations.

ECG & cardiac

Heart rate
SDNN (HRV)
pNN50
RMSSD
P-wave detector
QRS morphology analyzer
QT interval
T-wave detector
PR interval
ST segment analyzer
CV% of RR intervals
QRS estimator
AFib burden
AFib episodes
Average HR during AFib

Glucose & CGM

High Blood Glucose Index (HBGI)
Low Blood Glucose Index (LBGI)
M-value
GRADE
Glucose Management Indicator (GMI)
J-index
CONGA
Time Above Range (TAR)
Time in Range (TIR)
Time Below Range (TBR)

Activity & movement

Running cadence
Walking cadence
Running stride length
Walking stride length
Stride length estimator
Running distance
Walking distance
MVPA (moderate-vigorous activity)
Sedentary minutes
Activity bouts detector
Activity classifier
Step detector
ENMO calculator
METs calculator
Active energy burned
Basal energy burned
M10 / L5 RA
Intradaily Variability
Interdaily Stability

Sleep & circadian

M10 / L5 Relative Amplitude
Intradaily Variability (sleep)
Detrend signal
Plus configurable sleep staging

Frequency & signal

PSD calculator (power spectral density)
FFT magnitude calculator
Spectrogram calculator
Butterworth Lowpass filter
Butterworth Highpass filter
Butterworth Bandpass filter
Butterworth Bandstop filter
Notch filter

General purpose & QC

RMS calculator
Signal energy
Peak-to-peak
Zero-crossing rate
Standard deviation
Coefficient of variation
Array min/max
Array average
Interpolate missing values
Normalize signal
Median filter
Moving average filter
Savitzky-Golay filter
Detect outliers Z-score
Outlier detection MAD
Change point detection (PELT)
Walking speed
Running speed
Walking asymmetry
Running asymmetry
Walking variability
Running variability

Aligned with the frameworks regulators and sponsors use

FDA DHT guidance Digital Health Technologies for Remote Data Acquisition (2024 final)

DiMe V3 framework Verification, Analytical Validation, Clinical Validation

ICH E6(R3) Data integrity, attributability, version control

21 CFR Part 11 Electronic records and signatures

Request the full algorithm validation pack See real-time compliance scoring →

Unified Clinical Dashboard

Endpoints, ePRO, and wearable signals combined into one clinical command center.

Engagement & Compliance Engine

Compliance is not a reminder problem. It’s an operational one. Delve combines automation with human intervention to keep studies on track—continuously.

Human Concierge Support

Onboarding, troubleshooting, reminders, and missed sync recovery.

Automated Issue Detection

Hardware failures, low battery, connectivity loss—caught instantly.

Closed-Loop Compliance

Automated triggers plus human outreach ensure continuous evidence collection.

95%+ Compliance

Industry-leading adherence across global, multi-device clinical studies.

95%

Device compliance

87%

Retention at 6 months

63%

Higher engagement vs. site-only workflows

Validation, Deployment & Global Scale

Digital measures only matter if they are defensible, deployable, and supported at scale. Delve operationalizes validation, global device logistics, and around-the-clock study support.

FDA/EMA Aligned

Fit-for-purpose validation and reproducibility checks for digital submissions.

Provisioning & Logistics

Shipping, SIM activation, returns, replacements, and inventory management.

BYOD + Medical-Grade

Support for both patient-owned and sponsor-provided wearables.

24/7 Global Support

Technical, patient-facing, and site support teams available worldwide.

Frequently asked questions

Wearables and digital measures for clinical trials

How does Delve turn wearable data into a clinical trial endpoint?

Delve runs 70+ validated digital-endpoint algorithms across 25+ devices on one harmonized data layer, then applies signal quality control to confirm the data is complete and usable. Raw sensor signal becomes a defensible digital measure rather than an unvalidated data feed.

Which wearable devices and modalities does Delve support for clinical trials?

Delve supports 100+ device and sensor types across modalities including ECG, glucose (CGM), activity, sleep, respiratory, and cardiovascular signals, via BYOD, provisioned, cellular, and non-app devices, so data collection does not depend on a participant managing an app.

How does Delve protect wearable signal quality and wear-time?

An active signal quality control layer validates completeness, flags drift, and catches sync failures before data is lost, while Concierge-as-a-Service recovers wear-time in 120+ languages before participants disengage. Around 95% device compliance is sustained with this human-supported model.

Can Delve run wearables alongside eCOA and ePRO in the same study?

Yes. Delve unifies wearable data with eCOA/ePRO, analytics, and concierge support in one platform, so wearable signal and patient-reported outcomes are managed together rather than across separate vendors.

Comparing wearable platforms?

Honest, side-by-side evaluations for clinical operations teams choosing a wearable platform — scored on signal quality, validated algorithms, wear-time, and execution.

2026 Comparison

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