Spirometry QC & session monitoring
Quality gates for home spirometry sessions — effort monitoring, acceptability thresholds, and rescue outreach within protocol windows.
Respiratory Clinical Trials
Protect the signal between exacerbations.
Respiratory studies degrade quietly: spirometry sessions get missed, SpO2 data drifts, symptom diaries go stale between visits, and exacerbations go unrecorded until the patient calls the site. Delve runs the between-visit operating model — real-time oversight and human follow-through — so gaps get closed early, not reconstructed at lock.
Whether you're measuring FEV1 decline in COPD, exacerbation frequency in asthma, progression in IPF, or post-market outcomes in pulmonary hypertension, Delve operationalizes protocol-driven routines with eCOA/ePRO, wearable SpO2 and respiratory rate workflows, spirometry QC, and concierge support — so you get usable evidence, not just collected signals.
COPD
Asthma
IPF / ILD
Pulmonary Hypertension
Cystic Fibrosis
Sleep-Disordered Breathing
RSV / Viral Respiratory
Spirometry QC
Owned
Session quality + recovery
Exacerbation capture
Live
Daily symptom + SpO2 alerts
Dropout risk
Lower
Concierge absorbs follow-up
Evidence chain flow: SpO2 and spirometry capture → symptom context → QC gates → early intervention → analysis-ready endpoints.
Designed for respiratory realities
More than a platform — an operational model that protects the evidence chain.
Respiratory programs depend on longitudinal signal quality and consistent patient behavior. Delve enforces spirometry session standards, monitors SpO2 wear-time, and rescues gaps before they become missing endpoint data.
Between-visit symptom and signal capture
Daily ePRO (dyspnea, cough, wheeze, rescue inhaler use) fused with continuous SpO2 and respiratory rate wearable data to detect drift before the next visit.
Lower site burden, higher patient support
Concierge absorbs device training, troubleshooting, spirometry coaching, and compliance follow-up — so site staff focus on clinical assessments, not logistics.
Where respiratory evidence breaks down
Respiratory trials don't fail loudly. They degrade between visits.
The most common source of missing respiratory endpoint data is not protocol failure. It's the operational gap between visits — missed spirometry sessions, declining ePRO adherence, deteriorating wearable wear-time, and exacerbations that go uncaptured because no one was monitoring between appointments.
Spirometry session drift
Home spirometry completion typically declines 15–30% over the first three months without structured follow-up. Sessions get missed, effort quality degrades, and the decline is invisible until data lock.
Delve monitors session completion and quality daily, triggering outreach before windows close.
Exacerbations go unrecorded
Patients in COPD and asthma trials often experience exacerbations between visits without reporting them. Events get missed or mis-timed, weakening the primary endpoint analysis.
Daily symptom monitoring combined with wearable SpO2 signals creates early warning before events escalate.
Long-duration fatigue in COPD and IPF
Trials running 12–24+ months see the steepest compliance decline in months 6–12. Sites cannot maintain high-touch engagement at scale. Patients disengage quietly.
Delve's concierge model maintains active between-visit engagement without increasing site burden.
End-to-end respiratory delivery
From protocol to endpoint — the execution layer between visits.
Delve manages the operational infrastructure from study startup through data lock. Each phase is staffed, monitored, and documented to protect signal quality and regulatory confidence.
Phase 01
Study startup & site enablement
Device provisioning, site training, participant onboarding, and spirometer setup aligned to protocol requirements.
Delve-ledPhase 02
Active monitoring & intervention
Daily spirometry QC, SpO2 wear-time tracking, ePRO adherence monitoring, and concierge outreach for any gap detected within 24 hours.
Delve-ledPhase 03
Exacerbation detection & capture
Symptom escalation detection fused with wearable signals. Documented event workflows and site escalation protocols aligned to the SAE/AE reporting pathway.
Delve + sitePhase 04
Data readiness & analysis support
Endpoint-ready spirometry and wearable datasets, ePRO completion summaries, deviation logs, and signal QC documentation for submission packages.
Delve + sponsorWhy Delve for respiratory
Traditional eCOA vendors deploy software. Delve operationalizes the protocol.
Most eCOA platforms give you a diary app and a compliance dashboard. What respiratory trials actually need is someone who owns the gap between the dashboard and the patient — and closes it before it becomes missing data.
⚠ Traditional eCOA only
Software-managed model
- Diary app deployed and monitored by the site
- Spirometry compliance flagged after the window closes
- Site absorbs all patient troubleshooting and follow-up
- No active between-visit engagement
- Wearable data collected but not operationally monitored
✓ Delve execution model
Human + digital model
- Spirometry QC monitored daily with intervention SLAs
- SpO2 wear-time tracked in real time with recovery workflows
- Concierge handles all patient outreach, coaching, troubleshooting
- Exacerbation detection via daily symptom + wearable fusion
- Site burden reduced — sites focus on clinical work
→ What you get with Delve
What changes in the data
- Higher spirometry session completion rates
- Fewer missed exacerbation events
- Cleaner FEV1, SpO2, and symptom burden endpoints
- Lower protocol deviation rates from missed assessments
- Faster interim readouts from cleaner longitudinal data
Common questions
Respiratory trial execution — what teams ask us most.
What respiratory endpoints does Delve support?
Delve supports spirometry workflows (FEV1, FVC, FEV1/FVC), SpO2 and oxygen saturation monitoring,
exacerbation capture (frequency, severity, timing), symptom burden via validated patient-reported scales
(SGRQ, CAT, mMRC, ACQ), inhaler adherence tracking, 6-minute walk test support, and sleep-disordered
breathing endpoints. We adapt to the specific endpoint strategy and schedule of assessments for each study.
Can Delve support home spirometry compliance?
Yes. Home spirometry is a frequent source of data loss — patients miss sessions, perform them incorrectly,
or stop completing them without anyone knowing in time to recover. Delve's concierge layer provides proactive
session reminders, real-time quality monitoring, and documented intervention within protocol windows when
sessions are missed or fail technical quality thresholds.
How does Delve help capture exacerbations in COPD or asthma trials?
Exacerbations are often missed or reported late because patients don't recognize or escalate symptom changes
in time. Delve's daily ePRO symptom monitoring, combined with wearable SpO2 and activity signals, creates an
early warning system. When patients trend toward exacerbation thresholds, concierge outreach escalates before
the event becomes a protocol deviation or an unrecorded endpoint loss.
Do you support long-duration studies like IPF or post-market respiratory programs?
Yes — and this is exactly where Delve's continuity model matters most. Engagement fatigue, visit tapering,
and silent drift accelerate in years-long programs. Delve maintains active between-visit monitoring and
human engagement throughout the study duration to prevent the quiet dropout that undermines long-term
respiratory evidence. We are specifically designed for studies where traditional site-led models run out of
bandwidth.
Can Delve integrate with our existing CRO and EDC?
Yes. Delve operates as a prime delivery partner or as an integrated compliance and patient support layer
alongside your existing CRO and EDC. Many sponsors use Delve specifically for the between-visit operational
layer — eCOA, wearables, concierge, and real-time oversight — while the CRO manages monitoring, regulatory,
and data management.
Ready to protect your respiratory endpoints?
Tell us what you're running. We'll show you how Delve protects it.
Whether it's a COPD outcomes study, an asthma program with home spirometry, an IPF trial with wearable endpoints, or a post-market follow-up — Delve can operate as your between-visit execution layer and keep the evidence chain intact from enrollment through data lock.