US-Based Clinical Research Organization

Your Research.
Executed Where
It Matters Most.

The Caribbean holds patient populations and disease profiles that barely exist in today's clinical data — and for sponsors, that gap is a genuine opportunity to build stronger, more representative evidence. Prescriptive Research helps you reach it without the usual risk of going abroad. We're a US-based CRO with a real presence in Jamaica — engaged local counsel and established regulatory relationships on the ground — so the work gets done locally while you contract with a single accountable US entity, under US standards, with full GCP rigor from day one.

Turnkey access to Caribbean and emerging market patient populations
Single US contracting point — one agreement, full accountability
GCP-standard design protecting your regulatory investment
FDA 21 CFR 312.120 compliant foreign study infrastructure
Our Services Start a Conversation
Sponsor Value
One US Contract. Full Operational Coverage.
Therapeutic Focus
Cardiovascular, Rare Disease & Specialty Therapeutics
Study Types
Phase 2–4 · Real-World Evidence · Post-Approval
Market Access
Caribbean Basin · Emerging Markets · Underserved Populations
GCP Compliant 21 CFR 312.120 IRB Oversight RWE Studies PRAD Registration
US-Based & Incorporated
GCP-Compliant by Default
FDA 21 CFR 312.120 Expertise
Single Sponsor Contract
Caribbean Market Pioneer
Why Sponsors Choose Us

The CRO Built for
Where Others Don't Go

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.

1
One Contract, Complete Coverage

Prescriptive Research is your single US contracting entity. We coordinate all consortium partners, sites, and academic institutions — so you have one agreement, one point of contact, and one accountable party.

2
Regulatory Certainty, Not Assumptions

We obtain every regulatory requirement as plain, written confirmation — no verbal assurances, no institutional attribution. In complex markets, certainty is a deliverable, not a given.

3
GCP from Day One

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.

4
Built-In Timeline Protection

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.

What We Do

End-to-End Clinical
Research Services

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.

01
Regulatory Strategy & Navigation

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.

02
Study Design & Protocol Development

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.

03
Site Activation & Clinical Monitoring

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.

04
Sponsor Contracting & Consortium Governance

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 — no ambiguity, no downstream disputes.

05
Data Management & Biostatistics

Rigorous data collection, validation, and statistical analysis producing submission-ready outputs. Our real-world evidence pipelines generate population-specific data suited for formulary applications, market access dossiers, and post-approval regulatory use.

06
Market Access & Prevalence Research

We generate the population-specific prevalence and effectiveness data sponsors need to support drug registration and national formulary inclusion in markets where that evidence base does not yet exist — creating a complete data-to-access pipeline.

Our Market Differentiation

Unlocking the
Caribbean Market

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.

Regulatory Pathways Already Established

PRAD drug registration, IRB strategy, and Ministry of Health engagement frameworks are in place — removing months of groundwork from your timeline.

Populations Underrepresented in Global Data

Caribbean populations carry distinct genetic profiles not captured in most existing trial data — creating a genuine scientific and commercial opportunity for sponsors.

Formulary & Market Access Pipeline

Studies run through Prescriptive Research generate the local data required for national formulary inclusion — creating end-to-end value from trial to patient access.

Distinct
Genetic Profiles

Caribbean populations carry hereditary disease variants significantly underrepresented in existing global clinical trial data — creating a high-value evidence gap for sponsors.

Accessible
World-Class Clinical Sites

We have established partnerships with leading Caribbean clinical research facilities capable of conducting international-standard trials to GCP requirements.

Compliant
FDA Foreign Study Framework

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.

Proven
Operational Frameworks in Place

Regulatory navigation, institutional relationships, and dual-track approval strategies developed through direct experience — not theoretical planning.

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 Mission
How We Work

The Standards We
Hold Ourselves To

Conservative Regulatory Posture

We apply GCP standards by default across all studies — protecting your data against future scrutiny and ensuring it serves its maximum possible regulatory utility.

Written Verification as Discipline

Every regulatory requirement is confirmed in writing before we act on it. In emerging markets, assumptions are a liability. We eliminate them.

Dual-Track Planning

For every official regulatory pathway, we build a parallel independent route. Sponsor timelines are protected even when local regulatory outcomes are uncertain.

Transparent Governance

Clear data ownership, documented IP agreements, and structured contracts — in place before work begins. No surprises mid-study.

Leadership

The Team

Colleen Toney, PharmD
Colleen Toney, PharmD
Chief Executive Officer & Founder

Founding principal of Prescriptive Research. Leads sponsor contracting, consortium governance, and operational strategy — with expertise in structuring compliant multi-party clinical research partnerships in emerging markets.

Dr. Cheryl Robertson, MD
Dr. Cheryl Robertson, MD
Chief Medical Officer

Board-certified interventional cardiologist providing medical oversight across all programs. Brings deep cardiovascular expertise and ensures GCP-compliant study design, patient safety, and clinical integrity.

Elvia J. Cervantes
Elvia J. Cervantes
Head of Quality

Quality and compliance leader with over three decades of FDA experience. Oversees Prescriptive Research's quality systems, GCP compliance, and audit readiness across every study.

Scientific Advisory Board

Our Advisors

Dr. Harold N. Alvarez, MD
Baptist Health South Florida
Clinical & Laboratory Medicine
Kimberley Downer, LLB
Grayson & Company, Jamaica
Caribbean Corporate & Regulatory Law
Olivia Derrett Plowright, LLB
Grayson & Company, Jamaica
Commercial Law & Dispute Resolution
Jay Elkareh, PharmD, PhD
Pharmaceutical Sciences
Investigational Pharmacy & Drug Accountability
Get In Touch

Let's Talk About
Your Program

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.

Email
info@prescriptiveresearch.com
Headquarters
United States
Response Time
Within 2 business days