Facilities & capabilities · Ponce, Puerto Rico
Equipped, staffed and trained to conduct Phase 1 through Phase 4 studies.
A feasibility team should be able to evaluate a site quickly. This page is written for that read — capability first, narrative second.
Site capability summary
Aspira Health — Ponce, Puerto Rico research facility
One of few organizations in Puerto Rico equipped for Phase 1, operating under US regulatory jurisdiction with escalation into the partnered health system.
Clinical space
Dedicated Phase 1 unit
Controlled dosing · confinement & overnight capability
Equipped and staffed for confinement periods, serial PK sampling and continuous staff coverage through the dosing and observation window.
Ambulatory / outpatient exam space
Screening · treatment · follow-up visits
Outpatient capacity for screening, treatment and follow-up windows running in parallel with inpatient cohorts.
Dedicated monitoring space
Private · access-controlled · for CRA visits
Private, badge-controlled space for on-site monitoring visits with adjacent access to source documentation.
EDC-equipped workstations
Role-based access · remote monitoring ready
Study-dedicated terminals for eCRF entry, query resolution and remote monitoring sessions under role-based access.
Sample handling & cold chain
Monitored -80 °C freezer storage
Continuous monitoring · alarm escalation · backup power
Long-term biological sample integrity protected by continuous temperature monitoring, alarm escalation and generator-backed power.
Monitored -20 °C freezer storage
Continuous monitoring · alarm escalation · backup power
Short and mid-term specimen retention on the same monitoring and escalation framework.
Refrigerated on-site sample processing
Temperature-controlled centrifugation
Processing inside protocol-defined windows on site, eliminating transport time between draw and stabilization.
IATA-certified biological shipping
Category A/B · trained in-house personnel
Dangerous-goods packing, documentation and courier coordination handled by certified staff, with certification kept current.
Investigational product
Temperature-controlled IP storage
Controlled access · continuous logging
Segregated, access-restricted storage with recorded excursions, reconciliation logs and defined escalation on alarm.
On-site IP management
Dispensing · accountability · reconciliation
Receipt through destruction handled on site, with unblinded pharmacy separation where the protocol requires it.
Safety & monitoring
Cardiac monitoring & 12-lead ECG
QT-sensitive & first-in-human designs
Scheduled and event-driven cardiac assessment with continuous monitoring capability in the Phase 1 unit.
Emergency crash cart & code response
On-site cart · ACLS-trained staff · escalation pathway
Documented code response capability with drilled escalation to the partnered health system for higher acuity.
Secure regulatory document storage
Access-controlled · retention-compliant
Essential documents held under controlled access with retention periods aligned to sponsor and regulatory requirements.
Inside the Phase 1 unit
Confinement, dosing and intensive sampling — under one roof.
Overnight stay capability, cardiac monitoring and on-site processing keep first-in-human and PK-heavy protocols inside a single controlled environment.
Operational readiness
Infrastructure is only credible when it is inspected.
Equipment lists do not pass audits — logs, calibration records, alarm escalation histories and trained staff do. Every capability on this page is maintained with documentation a monitor or inspector can review on request.
Cold chain
Barcoded specimens, controlled processing windows, reconciled shipment records.
Escalation pathway
Health-system adjacency for higher-acuity response through the Metro Pavia partnership.
The Puerto Rico advantage
Meet FDA diversity enrollment requirements without leaving US jurisdiction.
Sponsors have an expensive problem: diversity enrollment commitments they cannot fill on the mainland, and offshore alternatives that introduce regulatory risk, foreign data questions and a second oversight framework. Puerto Rico resolves both at once — and Aspira operates there today.
US territory. Full FDA jurisdiction.
Studies conducted in Puerto Rico run under the US regulatory framework — US IRB oversight, FDA inspection authority and ICH-GCP standards. No foreign data acceptance risk. No separate regulatory pathway. No parallel submission strategy to fund.
Diversity enrollment, inside the US system.
Puerto Rico offers access to a predominantly Hispanic/Latino population within US jurisdiction — directly addressing the Diversity Action Plan requirements sponsors must now meet under FDORA 2022. Targets that stall on the mainland can be met here without leaving the US regulatory system.
Fully bilingual operations.
English and Spanish across clinical, regulatory and patient-facing functions — consent, source documentation, monitoring interaction and participant communication. Nothing is translated after the fact.
Established healthcare infrastructure.
Our strategic partnership with Metro Pavia Health Systems provides island-wide patient access through an operating health system, rather than a referral network assembled per protocol.
Engagement and retention culture.
Participants stay in studies here. Community trust, continuity of care and treatment-naive populations in several therapeutic areas produce cleaner signal and fewer dropouts.
Why the geography works
US regulatory framework
FDA jurisdiction, US IRB oversight and ICH-GCP applied to every study conducted on the island.
Hispanic/Latino population share (sample)
Sample value pending verified census confirmation — replace before publication.
Diversity Action Plans, in practice. FDORA 2022 obliges sponsors to specify enrollment goals by race, ethnicity, age and sex — and to explain how they will be met. Puerto Rico lets that plan be executed under a single regulatory system.
Population and enrollment figures shown are sample values pending client verification
Next step
Send us your Phase 1 feasibility questionnaire.
We will return the completed capability profile, staffing model and available capacity windows under confidentiality.