High-touch engagement (patient + caregiver)
Concierge outreach prevents silent drift: missed diaries, missed wear time, and escalating caregiver burden.
Rare Disease Programs
In rare disease, you don’t get “extra patients.” Every data day matters. Delve protects the endpoint by owning engagement, logistics, and compliance operations.
Rare disease trials carry unique failure modes: long travel, caregiver fatigue, pediatric complexity, fragile routines, and small sample sizes where each dropout materially changes power and interpretability. Delve combines CRO-style execution with a real-time compliance operating model: wearable endpoints, eCOA/ePRO, eConsent, device provisioning, and multilingual concierge follow-through—with audit-ready evidence of every intervention.
Ultra-rare / small cohorts
Pediatric + caregiver workflows
Hybrid / decentralized (as scoped)
Longitudinal monitoring
Natural history alignment
Site network coordination
Home nursing (as scoped)
Global, multilingual support
Engagement ops
Owned
Concierge follow-through
Wearable endpoints
QC’d
Continuity + telemetry
Evidence trail
Audit-ready
What happened + actions
Built for rare disease realities
Because the hard part isn’t enrollment. It’s holding the evidence chain together.
Rare disease execution is a logistics and engagement problem first—and a data problem second. Delve reduces missedness, prevents dropouts, and documents every recovery action so outcomes remain interpretable.
Wearables that protect interpretability
Telemetry and QC gates detect gaps early—so data is recovered inside protocol-defined windows, not after the fact.
Logistics + chain-of-custody
Kits, replacements, and time-sensitive shipments managed with evidence trails—reducing site burden and delays.
Why Delve
Rare disease trials are not “monitoring-managed.” They are relationship- and failure-mode-managed.
In rare disease, the cost of a missed week is not just a missing value—it can be an uninterpretable trajectory. Delve owns the day-to-day operations that traditional models often leave to sites or scattered vendors.
Traditional CRO
Strong on plans, weaker on daily follow-through
- Monitoring and periodic site contact
- Processes defined; execution varies by site bandwidth
- Issues surface after trends appear
- Between-visit accountability is unclear
Risk: small cohort + variable execution = missingness, deviations, and preventable dropouts.
CRO + point tools
More tools, more handoffs
- Separate vendors for wearables, ePRO, reminders, logistics, home visits
- Disconnected escalation paths and delayed response
- Sites absorb troubleshooting and caregiver outreach
- QC becomes retrospective clean-up
Risk: the dataset locks with gaps—and “data rescue” becomes the study plan.
Delve delivery model
Owned engagement + owned telemetry
- Concierge-led follow-through with caregiver-ready workflows
- Wearable continuity, sync, and wear-time monitoring
- Protocol-driven alerts, interventions, and escalation
- Evidence trails: what happened, actions taken, outcome
Outcome: higher usable data yield, fewer deviations, lower site burden, stronger retention.
Rare Disease Evidence Chain
Engagement + wearables + logistics + documented interventions = usable endpoints.
Rare disease evidence is fragile: small samples, heterogeneity, and longitudinal endpoints mean missingness can change the story. Delve closes the loop with telemetry, quality gates, and documented interventions when the chain breaks.
Engagement: caregiver-ready workflows, multilingual support, proactive outreach to prevent drift
Capture: wearables + eCOA/ePRO aligned to protocol windows and endpoint intent
Rescue: troubleshooting, re-training, replacements, scheduling support—documented and auditable
What’s different in rare disease
The non-negotiables that decide whether your study holds up.
Rare disease studies need more than “technology.” They need an execution layer that anticipates failure modes and closes them fast. Here is what Delve operationalizes—because these are the places rare studies break.
1) Caregiver and pediatric complexity
Many rare disease programs rely on caregivers, mixed reporting, and pediatric routines—where fatigue is the hidden risk.
- Caregiver-aware reminders, training, and escalation
- Flexible workflows (patient vs caregiver reporting)
- Support for remote consent / assent as scoped
Outcome: fewer missed diaries and fewer avoidable dropouts.
2) Longitudinal endpoints and missingness risk
When endpoints are trajectories, missing weeks can change interpretability more than missing visits.
- Wear-time and device-health telemetry
- Protocol-defined windows + data rescue workflows
- Intervention logs tied to QC flags
Outcome: analysis-ready datasets with transparent handling.
3) Logistics that can’t slip
Kits, replacements, and shipments are part of the endpoint. Delays become deviations and lost windows.
- Device provisioning + rapid replacements
- Chain-of-custody tracking and documentation
- Home visit coordination (labs/vitals/training) as scoped
Outcome: fewer disruptions, lower site follow-up burden.
How We Engage
Flexible models—from prime execution to CRO integration.
Full-Service Rare Disease Delivery (Prime)
Delve leads execution end-to-end with a rare disease operating model built around high-touch engagement, telemetry-driven QC, logistics coordination, and documented interventions. Specialty functions can be delivered directly or through Delve-led partners as scoped.
- Start-up coordination and readiness tracking
- Wearables + eCOA/ePRO + eConsent
- Compliance + retention operations owned
Hybrid With Your CRO
Keep your CRO for monitoring/EDC and plug Delve in as the digital capture + engagement operations layer. We reduce missingness, improve 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 follow-up work—device troubleshooting, caregiver outreach, reminders, rescheduling, and re-training—so sites can focus on clinical oversight.
- 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 showing how we monitor wear time, diary completion, and intervention response in real time. Your study’s dashboards reflect your protocol, schedules, and site structure.
Wear-time continuity with interventions
Markers indicate documented interventions (coaching, troubleshooting, replacements) that prevent gaps.
ePRO completion (patient/caregiver)
Proactive outreach reduces missed entries and supports retention across long follow-up periods.
Time-to-resolution for issues
Rapid recovery protects protocol windows—especially when cohorts are small and endpoints are longitudinal.
Protocol-to-Analysis
End-to-end rare disease delivery—mapped to real failure points.
“End-to-end” means ownership with evidence trails—from operationalizing the protocol and caregiver flows through compliance rescue, logistics coordination, data QC, and analysis readiness.
Step 1
Protocol operationalization
- SOA converted into executable tasks and windows
- Risk register: caregiver fatigue, travel friction, device gaps
- Intervention rules + escalation pathways defined
Step 2
Endpoint + device strategy
- Wearables mapped to endpoint intent and feasibility
- Telemetry plan: wear-time, sync, battery, QC flags
- Handling rules and missingness surveillance
Step 3
Site + patient journey design
- Caregiver workflows and training design
- Visit windows, travel reduction, and remote touchpoints
- Readiness tracking for sites and patients
Step 4
Onboarding + routines
- Patient/caregiver training: wearables, ePRO, consent as scoped
- Routines aligned to protocol windows
- Multilingual concierge support for ongoing questions
Step 5
Conduct: adherence operations
- Real-time monitoring: wear-time, diaries, missed windows
- Concierge outreach when compliance drifts
- Documented interventions + outcomes (audit-ready)
Step 6
Logistics + home services
- Provisioning, replacements, and kit workflows
- Home nursing/labs coordination as scoped
- Chain-of-custody documentation and status visibility
Step 7
Data quality + reconciliation
- QC checks, missingness rules, and flags
- Reconciliation across wearable + ePRO streams (as scoped)
- Site/network performance monitoring 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 review (as scoped)
Rare Disease Capabilities
Designed for small populations and high variability—without losing rigor.
Patient + caregiver engagement operations
Rare disease studies succeed when daily routines hold. We make adherence a managed process, not a hope.
- Caregiver-aware workflows and scheduling support
- Multilingual concierge follow-through and troubleshooting
- Escalation to sites with clear ownership and documentation
Wearables for objective signal and continuous context
Wearables reduce reliance on infrequent site visits and help characterize longitudinal change.
- Wear-time estimation + telemetry monitoring
- Continuity and QC gates tied to protocol windows
- Fit-for-purpose device selection and provisioning
Logistics that reduce deviations
In rare disease, logistics is clinical. We run the operational layer that protects visit windows and sample integrity.
- Kit workflows, replacements, and patient-friendly shipping
- Home visit coordination (training, vitals, collections) as scoped
- Audit-ready logs and status visibility for teams
Deliverables
What you receive when Delve runs rare disease execution.
- Operational study plan + rare disease execution risk register
- Patient/caregiver engagement plan + escalation pathways
- Wearables plan: device selection, provisioning, telemetry monitoring, replacement SOP
- eCOA/ePRO plan: schedules, reminders, training scripts, routing rules
- Data quality plan: QC checks, missingness rules, documented handling approach
- Weekly risk report: adherence, retention, device health, site performance
- Close-out evidence package: intervention logs, adherence summary, QC outcomes
Small populations demand operational certainty
Rare disease studies are often constrained by cohort size, geography, and caregiver burden. Delve operationalizes engagement, telemetry, and logistics—and documents every intervention—so your endpoints remain interpretable.
- Continuous monitoring of wear time, diary completion, and protocol windows
- Documented interventions (what happened, when, why, outcome)
- Logistics visibility for kits and replacements (as scoped)
- Exports aligned to your analysis plan and endpoint strategy (as scoped)
If you already have DM/biostats partners, Delve strengthens the operational evidence chain without replacing your stack.
Planning a rare disease study?
If your evidence depends on retention, longitudinal completeness, and caregiver-friendly execution, Delve is built for that. We can lead end-to-end execution or integrate with your CRO to improve compliance, reduce site burden, and increase usable data yield.