Signal health & sync monitoring
Device telemetry surfaces drop-offs early—battery, connectivity, wear-time, and missing data windows.
CNS Clinical Trials
CNS endpoints fail quietly—through missed diaries, device drop-off, cognitive fatigue, and inconsistent routines. Delve prevents that.
CNS studies live and die between visits: fluctuations in sleep, activity, gait, tremor, cognition, mood, and adherence. Delve combines CRO-style execution with a real-time compliance operating model—wearables + eCOA/ePRO + concierge follow-through + kit logistics + live oversight—so you get usable evidence, not just collected data.
Alzheimer’s & Dementia
Parkinson’s
Multiple Sclerosis
Epilepsy
Depression
Schizophrenia
Migraine
ALS
Wearable adherence
Owned
Wear-time, sync, signal health
Data quality
Live
QC + missingness alerts
Site burden
Lower
Concierge absorbs follow-up load
Designed for CNS realities
More than a platform—an operational model that protects the endpoint.
CNS endpoint integrity depends on continuous capture and consistent routines. Delve monitors wearable signal health, rescues adherence drift, and documents interventions—before missingness becomes the headline.
Wearables for objective CNS endpoints
Sleep, activity, gait, tremor proxies, and circadian patterns—captured continuously, QC’d, and export-ready.
Adherence operations + retention
Concierge outreach, coaching, and troubleshooting—reducing site workload and preventing avoidable discontinuations.
Why Delve
CNS trials are not “visit-managed.” They are variability-managed.
CNS data deteriorates through day-to-day friction: participants forget, fatigue accumulates, devices desync, and symptoms fluctuate outside clinic windows. Delve closes these gaps by owning adherence operations and wearable telemetry— continuously, not retrospectively.
Traditional CRO
Strong at visits and monitoring
- Site oversight and monitoring cadence
- Templates, plans, and reporting structure
- Issue escalation after findings emerge
- Limited ownership between visits
Risk: CNS variability and wearable drop-off accumulate quietly; the signal degrades before anyone intervenes.
CRO + point tools
More tools, more gaps
- Separate vendors for wearables, ePRO, reminders, logistics
- Disconnected data streams and unclear accountability
- Sites absorb troubleshooting and follow-up
- QC happens after weeks of drift
Risk: missingness becomes the story, not the endpoint.
Delve delivery model
Owned compliance + owned wearable telemetry
- Live wear-time, sync, and signal health visibility
- Concierge team intervenes when drift appears
- Protocol-driven adherence rules + escalation pathways
- Evidence trails: what happened, actions taken, outcome
Outcome: higher usable data yield, fewer deviations, lower site burden, stronger retention.
CNS Evidence Chain
Wearables + eCOA + interventions = usable CNS endpoints.
CNS endpoints are sensitive to missingness and day-to-day variability. Delve closes the loop with telemetry, quality gates, and documented interventions when the chain breaks.
Wearables: wear-time, sync success, signal drop, sleep/activity/gait proxies
eCOA/ePRO: cognition, mood, fatigue, sleep QoL, symptom events, caregiver inputs
Interventions: concierge troubleshooting, coaching, replacements, escalation to sites
How We Engage
Flexible models—from prime execution to CRO integration.
Full-Service CNS Delivery (Prime)
Delve leads execution end-to-end with a CNS operating model built around continuous monitoring, adherence rescue, and protocol-defined interventions. Specialty functions can be delivered directly or through Delve-led partners as scoped.
- Start-up + site coordination
- Wearables + eCOA + patient operations
- Real-time QC + compliance + retention ownership
Hybrid With Your CRO
Keep your CRO for monitoring/EDC and plug Delve in as the wearable + adherence + patient operations layer. We reduce missingness, improve device adherence, and provide live risk visibility.
- Delve owns telemetry, compliance ops, and concierge support
- Protocol-driven alerts + escalation pathways
- Cleaner datasets at lock with fewer late-cycle fixes
Site Network Enablement
We offload the most time-consuming CNS follow-up work—device troubleshooting, diary completion outreach, reminders, and re-training—so sites can focus on assessments and enrollment.
- Coordinator relief: onboarding, reminders, rescheduling
- Device replacements and patient coaching
- Study-wide oversight dashboards for networks
Live Metrics (Example)
What sponsors and study teams see in Delve.
These are example visuals to demonstrate how we monitor wearable adherence, ePRO completion, and signal health in real time. Your study’s dashboards reflect your protocol, schedules, and site structure.
Wear-time trend with interventions
Markers indicate documented interventions (coaching, replacements, troubleshooting) that prevent drift.
Signal health (sync success)
Telemetry surfaces connectivity and dropouts early so teams can recover data within protocol windows.
Diary completion by site
Sites with higher friction get proactive concierge support and targeted retraining workflows.
Protocol-to-Analysis
End-to-end CNS delivery—mapped to real failure points.
“End-to-end” means ownership with evidence trails—from protocol operationalization and wearable selection through compliance rescue, data QC, and analysis readiness.
Step 1
Protocol operationalization
- SOA converted into executable tasks and visit windows
- CNS risk register: fatigue, cognition burden, device adherence
- Intervention rules + escalation pathways defined
Step 2
Wearables + endpoint mapping
- Device selection aligned to endpoint intent and feasibility
- Telemetry plan: wear-time, sync, battery, signal QC
- Handling rules for missingness and QC flags (as scoped)
Step 3
Feasibility + site enablement
- Site/network strategy aligned to indication and burden
- Start-up coordination and readiness tracking
- Training workflows for coordinators and investigators
Step 4
Onboarding + routines
- Patient training: wearables, syncing, diaries, reminders
- Caregiver workflows when relevant (as scoped)
- Multilingual concierge support for ongoing questions
Step 5
Conduct: adherence operations
- Real-time monitoring: wear-time + diaries + task completion
- Concierge outreach when compliance drifts
- Documented interventions + outcomes (audit-ready)
Step 6
Safety & symptom escalation
- Protocol-driven triggers for worsening symptoms/AE signals
- Structured routing to site/sponsor teams
- Evidence trails of follow-up actions and closure
Step 7
Data quality + reconciliation
- Wearable QC, missingness surveillance, and flags
- Reconciliation across ePRO, devices, and exports (as scoped)
- Monitoring of site/network performance and retraining needs
Step 8
Analysis readiness + close-out
- Analysis-ready exports and documented handling rules
- Close-out package: adherence summary + QC outcomes
- Support for interim looks and endpoint performance review (as scoped)
CNS Capabilities
Execution built for CNS realities.
Wearables that survive the real world
CNS endpoints often require continuous capture. We operationalize wear-time, telemetry monitoring, and replacements.
- Device provisioning, training, and replacements
- Signal health monitoring: battery, sync, connectivity
- Wear-time estimation + compliance rescue workflows
Patient burden management
CNS participants face fatigue, cognition load, and fluctuating symptoms. Delve prevents dropout by simplifying routines.
- Protocol-driven reminders and micro-coaching
- Concierge support for confusion and friction
- Caregiver workflows where needed (as scoped)
Objective + subjective data, reconciled
Wearable signals and ePRO must align to be interpretable. We monitor missingness and document intervention context.
- eCOA/ePRO for mood, cognition, fatigue, sleep, QoL
- QC checks and missingness rules (as scoped)
- Audit-ready intervention trails to explain variability
Deliverables
What you receive when Delve runs CNS execution.
- Operational study plan + CNS execution risk register
- Wearables plan: provisioning, telemetry monitoring, replacement SOP
- Adherence plan: wear-time + sync + ePRO routines + scripts
- Data quality plan: QC checks, missingness rules, reconciliation approach
- Weekly risk report: compliance, retention, device health, site performance
- Close-out evidence package: intervention logs, adherence summary, QC outcomes
From daily behavior to analysis-ready evidence
CNS studies don’t fail because the endpoint is unclear. They fail because the routine breaks. Delve operationalizes wearable adherence, reduces burden, and documents interventions—so your datasets are usable.
- Continuous telemetry and 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.
Planning a CNS study?
If your endpoints depend on consistent behavior between visits—wearables, diaries, sleep capture, symptom reporting—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.