Real-time compliance monitoring
Missed tasks, late entries, and sync gaps surface while there’s still time to act.
eCOA & ePRO
eCOA and ePRO that patients actually finish.
Digital diaries and assessments with quality control built in, and a real person who follows up when a patient falls behind, so missing data never becomes the endpoint.
92–98%Observed diary completion
< 24hIssue visibility and escalation
120+Languages for patient support
Why eCOA datasets fail in real trials.
Most eCOA problems aren’t caused by the forms. They come from execution gaps nobody is staffed to close.
- Diary completion decays as studies get longer and patient burden rises.
- Sites can’t chase every missed task, sync issue, or training problem.
- Hybrid and decentralized designs add visits, devices, and reminders to coordinate.
- Late visibility turns small compliance issues into protocol and analysis risk.
30–60%Compliance decay risk over long follow-up when engagement is passive
40%Missing PRO exposure that can weaken interpretability
70%+Rise in operational complexity when ePRO, devices, and logistics combine
< 24hThe window teams need to realistically recover compliance
The Delve Compliance Execution Layer™
Traditional eCOA vendors deploy software. Delve pairs the software with people and oversight that keep completion and retention on track.
Human follow-up
Concierge teams step in when reminders aren’t enough, helping patients complete tasks and stay on protocol.
Less site burden
Sites don’t become help desks. Delve absorbs routine friction so coordinators stay on study-critical work.
Wearables + ePRO together
Subjective and objective data side by side for better context and endpoint sensitivity.
Quality control built in
Edit checks and early escalation cut reconciliation work and prevent avoidable deviations.
Retention for the whole study
Participation that holds for the life of the protocol, not just the first few weeks.
A form builder that respects the protocol.
Build protocol-aligned instruments in minutes, without waiting on custom development.
- PRO, ClinRO, ObsRO, and PerfO support
- Branching, scoring, conditional logic, and edit checks
- Audio, video, image capture, and guided multi-step tasks
- Visit windows, configurable completion logic, and version control
How patients feel and how they function, in one place.
Wearables capture objective signals. ePRO captures lived experience. Delve brings them together between visits.
- Activity, heart rate, HRV, SpO₂, sleep, respiratory, and metabolic signals
- Correlated with diaries, site forms, ClinRO, and scheduled visits
- Real-time trends and signal-aware follow-up
Where other eCOA vendors stop, people take over.
Software alone doesn’t fix low tech comfort, missed diaries, or device confusion. Concierge-as-a-Service™ is the safety net behind completion.
- Real-time follow-up on missed entries
- Multilingual coaching and troubleshooting
- Proactive outreach when a device or app fails
- Extra support for sites during high-burden periods
What it looks like in a study.
eCOA, wearables, analytics, provisioning, and human support usually live with different vendors. Delve runs them as one execution model.
Completion that held through treatment
Concierge follow-up on missed symptom and diary tasks kept completion stable across a high-burden protocol.
Higher daily symptom adherence
Connected home monitoring plus proactive patient support lifted daily diary adherence.
Faster data readiness
ePRO, devices, and real-time oversight in one workflow shortened the path to a clean dataset.
Go deeper.
The detail behind the approach, for teams evaluating eCOA in depth.
What is eCOA?
Electronic Clinical Outcome Assessment (eCOA) is the digital capture of patient-reported, clinician-reported, observer-reported, and performance outcomes in clinical trials. Modern eCOA systems must support decentralized protocols, longitudinal compliance monitoring, multilingual accessibility, device connectivity, and fast intervention when patients fall behind.
Delve Health is not just an eCOA vendor. Delve is the execution infrastructure behind completion, retention, and endpoint-ready data in decentralized, hybrid, and site-based studies.
The six-layer eCOA execution architecture
1. Outcome capture
ePRO, eClinRO, eObsRO, PerfO, images, audio, video, and scheduled assessments across mobile, tablet, web, or provisioned devices.
2. Compliance intelligence
Missed tasks, delayed windows, incomplete submissions, connectivity gaps, and at-risk engagement surfaced in real time.
3. Engagement orchestration
Reminders, multilingual outreach, behavioral nudges, and proactive support aligned to the protocol.
4. Site augmentation
Troubleshooting, follow-up, and patient support coordinated so sites aren’t overwhelmed by routine issues.
5. Data readiness
Configured exports, harmonized streams, and completion trends for analysis, oversight, and reporting.
6. Endpoint context
Wearables and connected devices add objective context to symptom diaries.
The three pillars of modern eCOA
Patient-centric and accessible
Adaptive, mobile-first, multilingual completion with multimedia guidance.
Protocol-driven and researcher-controlled
Branching logic, edit checks, scheduling, scoring, and version control without engineering delays.
Connected to wearables and people
Objective signals plus concierge-supported completion for stronger, recoverable workflows.
How regulators evaluate eCOA
Regulatory confidence depends on whether the data are complete, attributable, timely, auditable, and controlled well enough to support interpretation of safety, efficacy, and patient experience.
Completeness
Missing longitudinal data weakens endpoint interpretation.
Auditability
Timing, structure, logic, and traceability must support inspection readiness.
Operational control
Teams need to see issues early enough to act, not during reconciliation.
eCOA across the development lifecycle
Phase I
Tolerability, safety symptoms, and early patient experience with rapid oversight.
Phase II
Symptom trends, burden patterns, and early efficacy-related outcomes.
Phase III
Endpoint integrity through stronger completion and early visibility into longitudinal risk.
Post-market
Long-duration follow-up and real-world evidence beyond visit schedules.
Hybrid studies
Site visits, remote tasks, devices, and support without splintering the patient experience.
Decentralized trials
Oversight beyond the site with mobile workflows, provisioned devices, and real-time signals.
Wearable types supported
Add objective measures when they improve endpoint sensitivity. Delve monitors device health, data flow, and compliance, then escalates with human outreach when needed. Devices can be BYOD or provisioned kits with SIM.
Activity & sleep
Wear time, steps, sleep duration and quality, circadian patterns.
Cardiovascular
Heart rate, rhythm flags, BP, and ECG-related measures.
Glucose & metabolic
CGM, glucometers, scales, and metabolic tracking.
Respiratory
Spirometry and home monitoring alongside symptoms.
SpO₂ & physiologic
Oxygen saturation, pulse, and signal-quality trends.
Sleep labs & home sleep
Sleep staging and longer-term home monitoring.
Temperature & vitals
Body temperature and vital signs for safety and context.
Multi-modal sensors
Composite endpoints combining multiple device streams.
Considerations by therapeutic area
CNS
Cognitive burden, fatigue, variable engagement, and simplified task design.
Oncology
High-burden protocols, symptom volatility, and retention-sensitive tracking.
Rare disease
Small populations, caregiver workflows, and white-glove support.
Cardiovascular
Long follow-up, wear-time stability, and gradual compliance decay.
Respiratory
Daily symptom variability and home monitoring.
Metabolic
CGM, weight, behavior, and multi-source harmonization.
What actually happens when eCOA is deployed
Patients miss tasks for human reasons
Travel, fatigue, low digital comfort, and confusion all affect completion.
Sites can’t carry infinite burden
Coordinators shouldn’t troubleshoot every device or chase every diary.
Device issues need fast escalation
Battery, pairing, sync, and provisioning problems quietly create missing data.
Late visibility is expensive
The later missing data is found, the fewer recovery options remain.
The cost of poor eCOA execution
Protocol stress
Weak completion forces workarounds or unplanned corrective effort.
Statistical risk
Longitudinal gaps reduce confidence in patient-reported outcomes.
CRO and site rework
Late discovery increases follow-up, reconciliation, and spend.
Delay pressure
Teams spend time explaining and compensating for missingness.
Retention drag
Engagement failure cascades into dropout in long studies.
Lost insight
Incomplete eCOA weakens the story the study was meant to tell.
Software-first vs execution-first
Traditional software-first model
Deploys forms, reminders, and dashboards, then assumes sites or sponsors will absorb the work of sustaining compliance.
Delve execution-first model
Builds the digital layer and the human operating layer together to protect participation and keep outcome data usable.
Where eCOA is heading
Predictive compliance
Spotting who is likely to disengage before data loss shows up in reports.
Adaptive task logic
Scheduling and intervention that respond to burden and missed patterns.
Multimodal endpoint fusion
Symptoms, function, behavior, and physiology in one picture.
Questions sponsors ask about eCOA.
What is eCOA in clinical trials?
eCOA is the digital capture of clinical outcome assessments, including ePRO, eClinRO, eObsRO, and PerfO. It replaces paper-based workflows with web, mobile, or provisioned-device data collection.
What is the difference between eCOA and ePRO?
ePRO is one subset of eCOA. eCOA is the broader framework for digital outcome assessment, while ePRO focuses specifically on data reported directly by patients.
Why do eCOA programs struggle even when the technology looks good?
Because study performance depends on execution. Patients need onboarding, reminders, support, troubleshooting, and follow-up. Sites need relief. Missing data often begins as an operational issue, not a technology issue.
How does Delve Health improve compliance and retention?
Delve combines configurable digital workflows with real-time quality control, wearable integration, multilingual support, and Concierge-as-a-Service™ that follows up when completion starts to fall.
Can Delve support both BYOD and provisioned devices?
Yes. Delve supports bring-your-own-device strategies and provisioned device models, including logistics, SIM-based devices, and fit-for-purpose deployment planning.
Can wearables be integrated with eCOA and ePRO?
Yes. Delve harmonizes wearable and connected-device data with patient-reported outcomes for better operational oversight and richer endpoint context.
Which studies benefit most from a compliance-focused eCOA model?
Longitudinal, high-burden, decentralized, hybrid, rare disease, CNS, oncology, cardiometabolic, and respiratory studies often benefit most because execution complexity is higher.
Does Delve reduce burden on sites?
Yes. Delve absorbs routine patient support, missed-task follow-up, and device troubleshooting so site teams can stay focused on clinical and protocol-critical work.
From the Knowledge Hub
Operational guides on eCOA from the team running these trials every day.
What is eCOA in Clinical Trials?
A working definition of electronic clinical outcome assessment and where it fits in modern trial designs.
Read →eCOA vs ePRO vs DHT
How these three categories differ, and why modern trials need all of them working together.
Read →How to Choose an eCOA Vendor
Evaluation criteria that go beyond software: execution, support, compliance, and site impact.
Read →Why eCOA Data Fails in the Real World
Missed diaries, patient drift, fragmented systems: the hidden failure modes and what fixes them.
Read →Multilingual Patient Support & eCOA Data Quality
How language coverage and cultural fit protect data quality in global trials.
Read →How to Measure Compliance in Clinical Trials
A practical, vendor-neutral framework for measuring compliance across modalities.
Read →Build your eCOA strategy around completion, not just forms.
If your study depends on patient-reported data, execution matters. Delve helps sponsors, CROs, and sites protect compliance and generate cleaner evidence.
Talk about your study Or try the 2-minute compliance calculator