SMO evolving into a full-service CRO
Clinical research that moves at the speed of discovery.
Aspira Health manages studies where patients actually are — from our Ponce, Puerto Rico base, and next across Latin America and the Philippines. Site-level execution, CRO-level oversight, one accountable partner.
Years of site management operations
Operating in Ponce, Puerto Rico
Core therapeutic areas in active delivery
Global footprint · live view
4 regions- Operating
- Expanding
- Planned
Ponce, Puerto Rico
Headquarters · Phase 1 capable unit · Metro Pavia Health Systems partnership
Why sponsors choose Aspira
A rare combination: Phase 1 capability inside US jurisdiction, plus emerging-market reach.
We are one of few organizations in Puerto Rico equipped to run Phase 1 studies, strengthened by a strategic partnership with Metro Pavia Health Systems and its patient access across the island.
Cumulative site footprint by year
Directional view of Aspira's operating footprint growth through the Puerto Rico expansion.
Leadership matters here. Aspira's leadership brings decades of combined US-based clinical research management experience — including site operations on 110+ trials for sponsors such as Pfizer, Merck and Novartis — into every new market we enter. The standards travel with us.
Metro Pavia
Strategic health-system partnership in Puerto Rico
Phase 1–4
Full lifecycle study delivery and oversight
GCP-aligned
Regulatory-ready documentation discipline
AiRA
Proprietary technology in active development
The SMO foundation
We don't broker access to sites. We operate them.
As a Site Management Organization, Aspira owns the infrastructure a protocol depends on — investigators, coordinators, regulatory and IRB submissions, recruitment and retention, and GCP-aligned quality systems applied identically at every location.
One SOP library. One training curriculum. One accountable operational counterpart for sponsors and CROs. That standardization is why our study start-up is fast, why data from one site looks like data from the next, and why sponsors can enter emerging markets without absorbing the operational risk of running sites there.
It is also the foundation we are scaling from — the same systems that make Aspira a trusted SMO today are what extend into full-service CRO delivery across Phase 1 through Phase 4.
How our SMO model worksOperational capabilities
Sponsors select sites on execution. Here is how we execute.
Activation speed, enrollment discipline, retention and query responsiveness — the operating measures that decide whether a study lands on time.
Rapid site activation
Start-up
Determines how quickly a sponsor's protocol begins generating data after site selection.
Disciplined enrollment execution
Recruitment
Predicts whether a study reaches its cohort without rescue sites or timeline extensions.
High patient retention
Participants
Dropouts erode statistical power; retention protects the evaluable dataset a submission rests on.
Responsive query resolution
Data
Query aging is the leading cause of database-lock delays between last visit and topline results.
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
Phase 1 capability · Ponce, Puerto Rico
One of few organizations in Puerto Rico equipped to run Phase 1.
Controlled dosing environments, continuous monitoring and intensive PK sampling — inside a US regulatory framework, with island-wide patient access through Metro Pavia Health Systems.
Facilities & capabilities
A spec sheet, not a claim.
Overnight Phase 1 beds, monitored -80 °C and -20 °C storage with backup power, controlled-access IP management, continuous cardiac monitoring, IATA-certified shipping and dedicated CRA monitoring rooms.
Therapeutic areas
Depth where protocols are hardest to enroll.
Our investigator relationships and patient communities are concentrated in six areas where recruitment, retention and data quality demand real operational experience.
Wound Care
Chronic and complex wound protocols
Cardiology
Interventional and device studies
Oncology
Early phase and supportive care
Gastroenterology
IBD, hepatology, motility
Nephrology
CKD and dialysis populations
Neurology
Neurodegenerative and pain
Inside operations
Enrollment, deviations and query aging reviewed weekly across every active site.
Chain of custody
Barcoded specimens, controlled processing windows, reconciled shipment logs.
Aspira Health Puerto Rico LLC
Precision is a standard, not a promise.
One quality system, one set of trained coordinators, one accountable operator — applied identically in Ponce today and in every market we enter next. Sponsors do not inherit our complexity; they inherit our discipline.
Next step
Bring us your hardest protocol.
Feasibility responses in days, not weeks. Tell us the indication, geography and timeline — we'll tell you exactly what we can commit to.