Prescriptive Research is a US-based CRO specializing in sponsor-ready clinical research in underserved and emerging markets. We give biotech and pharma sponsors access to patient populations that global trials have historically overlooked, with the regulatory precision and GCP rigor your program demands.
Most CROs serve established markets with well-worn regulatory paths. Prescriptive Research was purpose-built for something different, delivering the same rigor and accountability in markets that have historically been inaccessible to sponsors.
That means you reach patient populations your competitors have not. It means real-world evidence from demographics that are underrepresented in current data. And it means a regulatory infrastructure that protects your program from day one, wherever the study runs.
Prescriptive Research is your single US contracting entity. We coordinate all consortium partners, sites, and academic institutions, giving you one agreement, one point of contact, and one accountable party.
We obtain every regulatory requirement as plain, written confirmation, with no verbal assurances and no institutional attribution. In complex markets, certainty is a deliverable, not a given.
We apply conservative GCP standards as a default, not as overhead, but as protection. If your data may ever support an FDA submission, label extension, or market access filing, we design for that from the start.
We run dual-track regulatory pathways in parallel with official approvals. Emerging market uncertainty never becomes your timeline problem, because we have already built the independent path.
From first regulatory strategy conversation to final sponsor deliverable, Prescriptive Research manages every phase of the research lifecycle, so you can focus on your science while we execute the study.
We map the regulatory landscape before your study begins, identifying mandatory requirements versus best-practice guidance, obtaining written confirmations, and building dual-track pathways that keep your program moving regardless of local regulatory complexity.
GCP-aligned protocol development for Phase 2–4 trials and real-world evidence studies. We build in the endpoints, controls, and documentation standards that allow your data to serve multiple purposes, including regulatory submissions you may not yet be planning for.
Full-service site qualification, investigator onboarding, staff training, and ongoing monitoring, bringing sites in emerging markets to international standards efficiently, without sacrificing compliance or data integrity.
We serve as your single US contracting entity for multi-party research programs. Data use agreements, IP ownership, and academic partnerships are documented and governed from the outset, with no ambiguity and no downstream disputes.
Rigorous data collection, validation, and statistical analysis producing submission-ready outputs. Our real-world evidence pipelines generate population-specific data suited for regulatory submissions, post-approval use, and downstream patient access strategies specific to each market.
We generate the population-specific prevalence and effectiveness data sponsors need to support drug registration and broader patient access goals in markets where that evidence base does not yet exist. The pathway from data to access varies by market, and we design for the specific strategy each program requires.
The Caribbean is one of the most clinically significant untapped markets in the world. Distinct genetic profiles, high rates of cardiovascular and metabolic disease, and patient populations almost entirely absent from global clinical data, yet largely inaccessible to sponsors who lack on-the-ground infrastructure and regulatory expertise.
Prescriptive Research has built that infrastructure. We have navigated the regulatory landscape, established institutional partnerships at leading Caribbean clinical facilities, and developed the operational frameworks sponsors need to enter this market compliantly, efficiently, and with confidence. Prescriptive Research Jamaica Ltd, our on-the-ground operating subsidiary, is currently in formation in Kingston, providing local operational leadership and direct regulatory presence in-country.
We have mapped the regulatory landscape, covering drug authorization requirements, IRB strategy, and in-country compliance frameworks, so sponsors enter with clarity and without losing months to groundwork we have already done.
Caribbean populations carry distinct genetic profiles not captured in most existing trial data, creating a genuine scientific and commercial opportunity for sponsors.
Studies run through Prescriptive Research generate population-specific evidence that supports downstream patient access goals, whether that means drug registration, reimbursement pathways, or broader market access strategies tailored to the specific market.
Caribbean populations carry hereditary disease variants significantly underrepresented in existing global clinical trial data, creating a high-value evidence gap for sponsors.
We have established partnerships with leading Caribbean clinical research facilities capable of conducting international-standard trials to GCP requirements.
All Caribbean studies are structured under 21 CFR 312.120 with US Central IRB oversight, ensuring your data meets FDA standards regardless of where it is collected.
Regulatory navigation, institutional relationships, and dual-track approval strategies built from the ground up and designed for the realities of Caribbean market research, not adapted from elsewhere.
Clinical evidence should reflect the full diversity of the patients it is meant to serve. We exist to generate that evidence in the populations who need it most, and to make that work accessible to the sponsors who want to do it right.
Our MissionWe apply GCP standards by default across all studies, protecting your data against future scrutiny and ensuring it serves its maximum possible regulatory utility.
Every regulatory requirement is confirmed in writing before we act on it. In emerging markets, assumptions are a liability. We eliminate them.
For every official regulatory pathway, we build a parallel independent route. Sponsor timelines are protected even when local regulatory outcomes are uncertain.
Clear data ownership, documented IP agreements, and structured contracts, all in place before work begins. No surprises mid-study.
Doctor of Pharmacy, MCPHS. Extensive background in hospital-based clinical pharmacy, clinical research operations, and clinical supplies leadership across drug development programs. Healthcare consultant with a track record of engaging Jamaican government institutions and procuring government contracts in Jamaica, providing Prescriptive Research with established in-country relationships and operational credibility. Founded Prescriptive Research to bring GCP-standard clinical research infrastructure to the Caribbean basin and other underserved markets.
Board-certified interventional cardiologist and cardiovascular disease specialist. MD, University of Alabama School of Medicine. Residency, Duke University Medical Center. Fellowship in Cardiology and Interventional Cardiology, Vanderbilt University Medical Center. Member of the American College of Cardiology and American Heart Association. Currently practicing at Wellstar Cardiovascular Medicine.
Over 31 years at the US Food and Drug Administration as Investigations Branch Operations Coordinator, Supervisor, Compliance Officer, and Investigator, conducting GCP and GMP inspections across sponsor, PI, and CRO environments. Since 2018, Owner of Juarez FDA Auditing and Consulting Services Inc., providing compliance auditing across pharma, devices, and biologics. At Prescriptive Research, she architects the quality oversight infrastructure that governs site monitoring, GCP compliance, and sponsor-facing audit readiness, bringing the perspective of an FDA inspector to every layer of our operational framework.
If you are a sponsor exploring Caribbean or emerging market research, an academic institution seeking a compliant operational partner, or a clinical site interested in participating in international studies, we would like to hear from you.