Phase 1 unit · Ponce, Puerto Rico
One of very few Phase 1-capable organizations in Puerto Rico.
First-in-human and PK-intensive protocols run inside a single controlled environment, under US FDA jurisdiction, with escalation into a partnered health system.
Unit capability summary
Aspira Health Phase 1 unit — Ponce, Puerto Rico
Confinement and overnight capability, controlled dosing, serial PK sampling, cardiac monitoring and monitored cold chain — held to documentation a monitor can review on request.
Dosing & pharmacokinetics
Confinement & overnight capability
Continuous staff coverage through dosing and observation
The unit is equipped and staffed for confinement periods, with coverage maintained across the dosing and observation window rather than assembled per study.
Controlled dosing environment
First-in-human & single/multiple ascending dose designs
Dosing conducted in a dedicated, access-controlled environment with documented preparation, administration and post-dose observation steps.
Serial PK sampling
Protocol-defined windows · on-site processing
Intensive timed sampling supported by on-site temperature-controlled centrifugation, so specimens are stabilized inside the protocol window without transport time.
Ambulatory follow-up in parallel
Screening · treatment · follow-up visits
Outpatient capacity runs alongside inpatient cohorts, keeping screening and follow-up windows on schedule during an active confinement period.
Safety & cardiac monitoring
Cardiac monitoring & 12-lead ECG
QT-sensitive & first-in-human designs
Scheduled and event-driven cardiac assessment with continuous monitoring capability inside the unit for cardiac-liability protocols.
Crash cart & ACLS-trained staff
On-site cart · documented code response
Emergency response equipment on site with ACLS-trained personnel and a drilled, documented code pathway.
Rapid safety escalation
Escalation into the partnered health system
Higher-acuity events escalate into the partnered health system through an established pathway rather than an ad-hoc arrangement.
Secure regulatory documentation
Access-controlled · retention-compliant
Essential documents, safety reports and dosing records held under controlled access with compliant retention periods.
Cold chain & investigational product
Monitored -80 °C and -20 °C freezers
Alarm escalation · generator-backed power
Continuous temperature monitoring with alarm escalation and backup power, and excursion records available for review.
Temperature-controlled centrifugation
On-site processing inside protocol windows
Refrigerated processing on site so PK and biomarker samples are handled to specification from draw to storage.
IATA Category A/B shipping
Certified in-house personnel
Dangerous-goods packing, documentation and courier coordination handled by certified staff, with certification kept current.
Access-restricted IP storage
Continuous logging · reconciliation
Segregated investigational product storage with recorded excursions, accountability logs and unblinded pharmacy separation where the protocol requires it.
Inside the unit
Confinement, dosing and intensive sampling — under one roof.
Overnight stay capability, continuous cardiac monitoring and on-site sample processing keep first-in-human and PK-heavy protocols inside a single controlled environment.
Standardized meal timing and composition, unit capacity and emergency-transport proximity are confirmed in writing during Phase 1 feasibility review.
Why Puerto Rico for Phase 1
Early-phase capability inside US regulatory jurisdiction.
Puerto Rico operates under FDA oversight, so early-phase work here carries US regulatory framing without adding a foreign-jurisdiction submission path — alongside a population that supports enrollment diversity expectations.
PK handling
Barcoded specimens, controlled processing windows, reconciled shipment records.
Escalation pathway
Health-system adjacency for higher-acuity response through the Metro Pavia partnership.
Next step
Send us your Phase 1 protocol synopsis.
We will return unit capability, staffing model, monitoring plan and available capacity windows under confidentiality.