Clinical Services
Leveraging Puerto Rico's unique position as a premier clinical research hub — with 64+ hospitals and clinics and 200+ industry-sponsored trials annually — we provide end-to-end clinical trial management and regulatory coordination.
A Premier Clinical Research Hub in the Caribbean
Puerto Rico offers a unique combination of U.S. regulatory jurisdiction, a diverse and medically underserved patient population, world-class research infrastructure, and a bilingual workforce — making it an ideal location for clinical trials.
Complete Clinical Trial Support
Protocol Development
Scientifically rigorous clinical trial protocols designed to meet FDA, ICH E6 GCP, and IRB requirements from the outset.
Site Selection & Management
Access to Puerto Rico's network of 64+ hospitals and clinics. We identify, qualify, and manage sites to ensure enrollment and data quality.
IRB & Regulatory Submissions
Preparation and management of all IRB submissions, FDA IND amendments, and regulatory correspondence throughout the trial lifecycle.
Data Integrity & Monitoring
On-site and remote monitoring programs to ensure data accuracy, protocol compliance, and patient safety at every visit.
Phase I–IV Trial Support
Comprehensive CRO-level support across all clinical phases — from first-in-human studies to large-scale Phase IV post-market trials.
Biostatistics & Clinical Reporting
Statistical analysis plans, data management, and clinical study reports prepared to regulatory submission standards.
From Feasibility to Final Report
Feasibility Assessment
We evaluate your protocol, patient population, and site requirements to determine Puerto Rico's fit for your trial.
Site Identification
Leveraging our network of 64+ hospitals and clinics, we identify and qualify the optimal sites for your study.
Regulatory Preparation
All IRB submissions, FDA interactions, and site contracts are prepared and managed by our regulatory team.
Trial Execution
Our monitors ensure protocol compliance, data integrity, and patient safety throughout the trial.
Reporting & Submission
Clinical study reports and regulatory submissions are prepared to the highest standard for agency review.
Ready to leverage Puerto Rico's clinical research advantage?
Our bilingual team is ready to assess your trial's feasibility and connect you with the right sites.