For clinical development leaders · Severe asthma
Pluto pre-screens severe-asthma populations against your protocol — exacerbation history, ICS/OCS dosing, lung function, comorbidities — so sites receive likely eligible patients instead of lead lists. Your team spends screening visits enrolling, not disqualifying.
US health systems pre-screened
average time to pre-screen (vs. weeks)
screen-in rate at sites
The problem
Moderate-to-severe asthma protocols require medium-to-high-dose ICS, ≥2 systemic-corticosteroid courses in the prior year, and a specific age band. That patient lives in the EHR — not in a database your recruitment vendor can query.
The 12–17 cohort enrolls through families, schools, and pediatric pulmonology — channels traditional adult-trial outreach was never designed for. Most programs underenroll this arm by 40% or more.
Two weeks screening, four weeks run-in, fifty-two weeks treatment, thirty-eight weeks follow-up, plus a ninety-week open-label extension. Dropout compounds at every phase, and per-patient replacement cost is non-trivial.
The playbook
One operational backbone — data, clinical, and care delivery — replacing a patchwork of recruitment vendors, site-by-site contracts, and patient-engagement point solutions.
01
Query structured EHR data across ~90% of US health systems for exact protocol criteria — ICS dose tier, exacerbation count, indication duration, age range — in a single pass.
02
Pluto's clinical team confirms eligibility through chart review, reconciles medications across every provider in the patient's record, and closes preventive-care gaps before site hand-off. Sites get warm, qualified referrals — not lead lists.
~3x site enrollment vs. traditional recruitment vendors (Pluto benchmark).
Anti-TSLP severe-asthma · Ph3
Pre-screen worklist
Primary care · System A
Pulmonology · System B
ED · System C
✓ Reconciled · 1 duplicate ICS resolved (fluticasone) · 2 OCS bursts confirmed for exacerbation count · rescue inhaler refill gap (90+d) flagged to care team
Pluto care team auto-schedules gaps via tele-visit, in-home services, and vaccine coordination — closed before site hand-off.
03
Clinical adjudications and support by clinicians, in-home phlebotomy, vaccine coordination, and adolescent caregiver workflows reduce participation burden — and reduce eligibility and retention problems that kills enrollment — stay engaged.
Pluto Care
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04
Coordinator outreach, eDiary nudges, visit-window scheduling, and adolescent caregiver touchpoints across screening, run-in, treatment, follow-up, and open-label extension — one team, one record, the whole arc.
Worked example
Illustrative only — composite criteria for a representative severe-asthma program. No specific sponsor, study, or investigational product is referenced.
TRIAL PROFILE
PLUTO SUPPORT ACROSS THE LIFE-CYCLE
Day 0
Eligibility query runs
Protocol criteria reviewed across primary care, specialty clinics, and hospitals. Results returned in minutes, not RFP cycles.
Week 1
Clinical pre-screen complete
Pluto's clinical team reviews charts, confirms eligibility, and reaches eligible patients (and adolescent caregivers) through approved channels.
Week 2
Warm hand-off to site
Confirmed candidates routed to the nearest activated site with a complete pre-screen packet. No cold leads.
Week 4
First randomized enrollments
Sites begin enrolling against a qualified pipeline — Pluto carries retention from screen through the 90-week extension.
Week 5
Continuous monitoring & health review
AI and automation flag potential fail-screens and adverse events in real time, with a clinical team reviewing and intervening alongside the tech to re-evaluate and reduce fail-screens.
Operational proof
Benchmark drawn from prior Pluto trial-recruitment engagements. Time-to-first-patient varies by protocol complexity, site activation status, and indication; we'll walk through your specific protocol on the call.
Why Pluto
How Pluto compares on the criteria your evaluation committee is already grading on.
| Criterion | Recruitment vendor | Site network | Pluto |
|---|---|---|---|
| Reach model | Funnel-level — digital ads, call centers | Site-level — local outreach only | Population-level — EHR query across systems |
| Pre-screen confirmation | After hand-off to site | At the site, by site staff | Upstream — clinical team confirms before site |
| Site contracting overhead | Per-site contracts | N/A (one site at a time) | One operational backbone across geographies |
| Adolescent (12–17) access | Limited — adult channels | Depends on pediatric pulmonology presence | Family- and caregiver-aware workflows |
| Retention infrastructure | Outsourced or absent | Site coordinator capacity-bound | Care delivery + eDiary + coordinator outreach |
| Data provenance | Third-party panels | Local chart access only | Direct EHR integrations, auditable |
Regulatory + data provenance
Pluto operates under Business Associate Agreements with connected health systems. Patient-identifying data is handled inside the covered-entity perimeter; population-level outputs are de-identified per HIPAA Safe Harbor.
Patient-facing eDiary, eConsent, and outreach tooling supports electronic records and signatures with audit trail, access controls, and validation documentation available for sponsor review.
Recruitment materials and patient communications are routed through IRB review per protocol. Sponsors retain visibility and approval on every patient-facing asset.
Every population query is logged with criteria, timestamp, and result counts. De-identification methodology for surfaced stats is documented and reviewable.
200M+
of US health systems
200M+
patient records
4
therapeutic areas with live pre-screening
Clinical, AI, and coordinated support working together across the trial life-cycle — from eligibility through continuous monitoring. Bring a protocol or a question about feasibility and we'll show you how the model runs against your criteria.
