Signal QC & continuity monitoring
Quality gates for ECG/wearables, uploads, and data gaps—plus rescue workflows within protocol windows.
Cardiovascular Trials
Protect the endpoint between visits.
Cardiovascular studies fail quietly: wear-time drops, ECG quality drifts, diaries go stale, and the “story” gets reconstructed at lock. Delve runs the between-visit operating model—real-time oversight + human follow-through—so missingness gets resolved early, not explained later.
Whether you’re measuring arrhythmia burden, BP control, functional capacity, symptoms, or post-market outcomes, Delve operationalizes protocol-driven routines with eCOA/ePRO, wearable and ECG workflows, logistics, and concierge support—so you get usable evidence, not just collected signals.
Heart Failure
Atrial Fibrillation
Hypertension
Ischemic Heart Disease
Post-MI / Secondary Prevention
Cardiometabolic
Wear-time continuity
Owned
Training + proactive rescue
Signal quality
Live
ECG/QC + gap alerts
Retention risk
Lower
Concierge absorbs follow-up
Evidence chain flow showing signal capture, symptom context, QC gates, interventions, and analysis-ready endpoints.
Designed for cardiovascular realities
More than a platform—an operational model that protects continuity.
Cardiovascular programs depend on high-fidelity longitudinal data. Delve enforces wear-time, validates signal quality, and rescues gaps before they become analysis risk.
Between visit adherence operations
Medication logs, BP routines, symptom reporting, and device habits reinforced by reminders and human follow-through.
Lower site burden
Concierge handles training, troubleshooting, rescheduling, and device support—so sites focus on clinical assessments.
Long-term cardiovascular follow-up
Lost to follow-up is where CV evidence quietly breaks.
Cardiovascular endpoints mature over months and years. As visit cadence tapers, traditional trial infrastructure fades — and participants drift without anyone truly owning continuity. Delve is built to keep the evidence chain intact between visits, when drop-off risk is highest and recovery windows close fast.
The CV reality: the trial doesn’t end at the visit.
Most operational models are visit-managed. Cardiovascular studies must be continuity-managed — especially in post-market and outcomes programs where the “distance” between touchpoints is measured in months.
Visit cadence fades
Engagement declines
Signals drift silently
Recovery windows close
Sites absorb the chase
Quiet drop-off becomes visible
Continuity monitoring detects drift early — wear-time gaps, missed routines, delayed uploads, and stale symptom capture.
Follow-through is owned (not “shared”)
Concierge-led outreach resolves friction in real time — coaching, troubleshooting, rescheduling support, and device swaps.
Evidence trails hold up at audit
Documented interventions: what happened, when it was detected, what actions were taken, and whether continuity recovered.
Long-duration, low-burden design
Protocol-driven routines that remain realistic at Month 12+ — reducing dropout risk without pushing burden back onto sites.
Wearables collect signals. Delve protects follow-up.
We keep participants engaged when they feel “fine,” keep sites out of the chase, and keep your longitudinal endpoints analyzable.
Why Delve
CV trials are not “visit-managed.” They are continuity-managed.
In cardiovascular research, the endpoint breaks through routine friction: devices aren’t worn, signals degrade, symptom context is missing, and follow-up slips. Delve closes these gaps by owning continuity operations and documenting interventions—continuously, not retrospectively.
Traditional CRO
Strong at visit cadence
- Monitoring and reporting structure
- Site communication and oversight
- Standardized processes and templates
- Issue escalation after findings emerge
Risk: longitudinal wear-time and ECG quality drift between visits; issues are discovered late and fixed expensively.
CRO + point tools
More tools, more failure points
- Separate vendors for ePRO, ECG, wearables, logistics
- Disconnected streams and unclear accountability
- Sites absorb follow-up, re-training, and troubleshooting
- QC happens after weeks of drift
Risk: “missingness” becomes the story, not the endpoint.
Delve delivery model
Owned continuity + owned follow-through
- Real-time wear-time and signal visibility
- Concierge intervenes when drift appears
- Protocol-driven QC rules and rescue workflows
- Evidence trails: what happened, actions taken, outcome
Outcome: higher usable data yield, fewer protocol deviations, lower site burden, stronger retention.
Cardiovascular Evidence Chain
Signal continuity + symptom context + interventions = usable endpoints.
Cardiovascular endpoints depend on longitudinal integrity. Delve closes the loop with QC gates, real-time alerts, and documented interventions when the chain breaks.
Signal QC: wear-time, ECG quality checks, uploads, gap detection
Symptom context: dyspnea, palpitations, dizziness, fatigue, meds/events
Interventions: concierge coaching, re-training, swaps, escalation pathways
How We Engage
Flexible models—from prime execution to CRO integration.
Full-Service Cardiovascular Delivery (Prime)
Delve leads execution end-to-end with a CV operating model built around continuity, signal quality, and real-time oversight. Specialty functions can be delivered directly or through Delve-led partners as scoped.
- Start-up + site coordination
- Patient operations + concierge follow-through
- eCOA/wearables/ECG/logistics + live quality control
Hybrid With Your CRO
Keep your CRO for monitoring/EDC and plug Delve in as the continuity, patient operations, and signal-quality layer. We reduce gaps, improve QC, and provide live risk visibility.
- Delve owns wear-time + patient support
- QC gates + rescue workflows + escalation pathways
- Cleaner datasets at lock with fewer late-cycle fixes
Site Network Enablement
We offload the most time-consuming follow-up—training, troubleshooting, reminders, rescheduling, device swaps—so sites can focus on clinical assessments and enrollment.
- Coordinator relief: reminders, training, rescheduling
- Participant coaching for devices and routines
- Study-wide oversight dashboards for networks
Live Metrics (Example)
What sponsors and study teams see in Delve.
Example visuals to demonstrate how we monitor wear-time, signal quality, and completion in real time. Your study’s dashboards reflect your protocol, schedules, and site structure.
Adherence trend with interventions
Markers indicate documented interventions that prevent drift.
Signal QC pass rate
Quality gates surface low-confidence segments early, enabling rescue within protocol windows.
Task completion by site
Sites with higher friction get proactive concierge support and targeted retraining workflows.
Protocol-to-Analysis
End-to-end cardiovascular delivery—mapped to real failure points.
“End-to-end” means ownership with evidence trails—from protocol operationalization and device workflows through continuity rescue, data QC, and analysis readiness.
Step 1
Protocol operationalization
- SOA converted into executable tasks and visit windows
- CV risk register: wear-time, ECG quality, follow-up
- Intervention rules + escalation pathways defined
Step 2
Device + endpoint workflow design
- Wearables/ECG/BP routines defined per protocol
- Quality gates: connectivity, wear-time, signal checks
- Rescue workflows before drift becomes missingness
Step 3
Feasibility + site enablement
- Site/network strategy aligned to burden and endpoints
- Start-up coordination and readiness tracking
- Training workflows for coordinators and investigators
Step 4
Onboarding + compliance setup
- Device setup, pairing, and routine reinforcement
- Patient training: ECG captures, BP, symptom capture
- Multilingual concierge support for ongoing questions
Step 5
Conduct: continuity operations
- Real-time wear-time/signal monitoring and alerts
- Concierge outreach when continuity drifts
- Documented interventions + outcomes (audit-ready)
Step 6
Safety & escalation routing
- Protocol-driven triggers for symptom/safety signals
- Structured routing to site/sponsor teams
- Evidence trails of follow-up actions and closure
Step 7
Data quality + reconciliation
- Missingness surveillance across devices and ePRO
- QC exceptions tracked and resolved
- Reconciliation across sources and exports (as scoped)
Step 8
Analysis readiness + close-out
- Analysis-ready exports and documented handling rules
- Close-out package: continuity + QC outcomes
- Support for interim looks and endpoint performance review (as scoped)
Cardiovascular Capabilities
Execution built for cardiovascular realities.
Wear-time continuity is the endpoint risk
Longitudinal CV signals are only credible if participants actually wear and upload consistently.
- Protocol-driven wear-time rules and alerts
- Human follow-through when adherence drifts
- Documented deviations + rescue actions with timestamps
Signal quality workflows that prevent unusable data
ECG and sensor artifacts quietly corrupt endpoints. We enforce QC before data is lost.
- Connectivity + data upload monitoring
- Quality gates (noise, contact, capture success)
- Re-capture loops and escalation to sites when needed
Symptom capture that matches real-world events
Events don’t happen on visit days. Your endpoint needs context without adding work for sites.
- ePRO schedules for symptoms, events, meds, QoL
- Concierge outreach for missed entries and confusion
- Site relief: fewer calls, fewer late reconciliations
Endpoints & Modalities
Fit-for-purpose digital capture for cardiovascular endpoints.
Delve supports common cardiovascular endpoint strategies by operationalizing routines, quality gates, and evidence trails—so data is interpretable and audit-ready.
Arrhythmia & rhythm burden
- ECG workflow + capture quality checks
- Event-triggered symptom context (palpitations, dizziness)
- Continuity monitoring + re-capture loops
Outputs: timestamped episodes, QC flags, event context, intervention logs.
Blood pressure & hypertension control
- Protocol-defined home BP routines + reminders
- Connectivity and upload monitoring
- Exception handling when routines drift
Outputs: BP series, adherence-to-window metrics, missingness reasons.
Functional capacity & QoL
- Wearables for activity/sleep context
- ePRO for dyspnea, fatigue, functional status
- Site burden relief via concierge follow-through
Outputs: longitudinal activity/sleep features + ePRO completion tracking.
Heart failure monitoring
- Symptom diaries + medication logs
- Wear-time and upload continuity enforcement
- Escalation routing when protocol triggers occur
Outputs: symptom trends, completion rates, escalation evidence trails.
Post-market follow-up
- Low-friction routines and retention playbooks
- Remote check-ins + re-engagement workflows
- Device logistics, swaps, and recovery tracking
Outputs: completion, continuity, and follow-up logs for RWE needs.
Data readiness & exports
- Quality gates + missingness rules documented
- Audit-ready intervention and exception logs
- Exports aligned to your protocol and analysis plan
Outputs: analysis-ready datasets with handling rules and traceability.
Deliverables
What you receive when Delve runs CV execution.
- Operational study plan + CV execution risk register
- Participant adherence plan: wear-time/ECG/BP routines + scripts
- Signal QC plan: continuity rules, alerts, rescue workflows
- Data quality plan: missingness rules, QC checks, reconciliation approach
- Weekly risk report: continuity, retention risk, QC, site performance
- Close-out evidence package: intervention logs, continuity summary, QC outcomes
From longitudinal signals to analysis-ready evidence
CV studies don’t fail because the endpoint is unknown. They fail because continuity breaks. Delve operationalizes routines, enforces QC, and documents interventions—so your datasets are usable.
- Continuous missingness surveillance across devices and ePRO
- Documented interventions (what happened, when, why, outcome)
- Reconciliation across digital sources and exports (as scoped)
- Readiness support for interim looks and endpoint reviews (as scoped)
If you already have DM/biostats partners, Delve strengthens the operational evidence chain without replacing your stack.
FAQ
Common questions from cardiovascular teams.
Short answers to the questions we hear from Clinical Operations, Digital, and Post-Market teams when planning CV studies.
Do you replace our CRO?
Delve can act as a prime delivery partner or integrate with your CRO. Many teams keep their CRO for monitoring/EDC and use
Delve as the between-visit continuity, patient operations, and signal-quality layer.
What CV endpoints do you support?
Common strategies include rhythm/arrhythmia workflows (ECG), BP routines, symptom and event capture (ePRO), functional
capacity context via wearables, heart failure monitoring, and post-market follow-up.
How do you improve wearable or ECG data usability?
We enforce protocol-defined quality gates and continuity rules (wear-time, uploads, QC flags) and run documented
intervention workflows—so drift is corrected early, not explained later.
Can you support global, multilingual participants?
Yes. Delve’s concierge layer supports participants in 120+ languages and is designed to reduce site burden through training,
troubleshooting, reminders, and follow-through.
Planning a cardiovascular study?
If your endpoints depend on longitudinal continuity—wearables, ECG, BP routines, symptoms, follow-up—Delve is built to protect that evidence chain. We can lead end-to-end execution or integrate with your CRO to improve compliance and retention.