US-Based CRO with Caribbean Operations

Your Research.
Executed Where
It Matters Most.

Prescriptive Research is a US-incorporated CRO with Caribbean operations 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.

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

Operational Structure

US Parent · Jamaica Operating Subsidiary · Single Sponsor Contract

GCP Compliant 21 CFR 312.120 IRB Oversight RWE Studies Drug Registration Advisory

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 Jamaica and the Caribbean, 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 — built on US GCP standards and in-country Jamaican expertise — that protects your program from day one.

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.

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.

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.

Built-In Timeline Protection

We run dual-track regulatory pathways in parallel with official approvals. Our Jamaica-registered operating subsidiary provides on-the-ground continuity — emerging market uncertainty never becomes your timeline problem.

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.

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. This includes advising sponsors on Jamaican drug registration requirements, local compliance obligations, and the sequencing of regulatory steps needed before study initiation.

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.

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.

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.

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.

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

Built for Jamaica
and the Caribbean

Jamaica and the Caribbean represent one of the most clinically significant untapped markets in clinical research. 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. Our US parent company serves as your single contracting entity, while our Jamaica-registered operating subsidiary provides on-the-ground execution, local regulatory expertise, and in-country institutional relationships. You sign one US contract — we handle everything in the field.

In-Country Regulatory Knowledge

We have developed deep working knowledge of Jamaica's regulatory and legal framework for clinical research — including drug registration requirements, local compliance obligations, and GCP-standard study conduct — removing months of groundwork from your timeline.

Populations Underrepresented in Global Data

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

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.

Integrated

US Standards + Local Expertise

Our Jamaica subsidiary team brings in-country regulatory knowledge and institutional relationships, merged with US GCP standards — a combination no other CRO offers in this market.

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.

Structured

Dual-Entity Operational Model

US parent for sponsor contracting and governance. Jamaica-registered subsidiary for on-the-ground execution, local compliance, and in-country institutional relationships — purpose-built for this market.

Clinical evidence should reflect the full diversity of the patients it is meant to serve. We exist to generate that evidence in Jamaica and the Caribbean — populations historically excluded from global research — and to make that work accessible to 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

Dr. Colleen Toney, Pharm D

Chief Executive Officer & Founder

PharmD and advanced-practice clinical pharmacist with progressive leadership across biotech drug development, clinical trial execution, and investigational product strategy. Currently serving as Head of Research and Development at Alliance International Medical (AIM), leading founding-stage advisory initiatives across healthcare and biotech. Background spans hospital-based clinical pharmacy, clinical research drug development, and executive-level clinical supplies leadership — with direct consulting experience supporting Jamaican healthcare institutions. Founded Prescriptive Research to bring GCP-compliant clinical research infrastructure to Jamaica and the Caribbean.

Dr. Cheryl Robertson, MD

Chief Medical Officer

Board-certified interventional cardiologist with fellowship training at Vanderbilt University and residency at Duke University Medical Center. Specialist in cardiovascular disease and internal medicine. Member of the American College of Cardiology and American Heart Association. Provides medical oversight across all Prescriptive Research clinical programs.

[Head of Regulatory Affairs]

Head of Regulatory Affairs

Specialist in FDA foreign study regulations, IRB strategy, and emerging market regulatory navigation. Architects the compliance frameworks and written verification protocols that protect every Prescriptive Research engagement.

Scientific Advisory Board

Our Advisors

Dr. Harold N. Alvarez, MD

Baptist Health · Miami, Florida

Pathology & Diagnostic Medicine — 20+ years clinical experience

Kimberley Downer, LLB

Attorney-at-Law · Grayson & Company · Jamaica

Jamaican Legal Counsel — Litigation, Compliance & Regulatory Affairs

[Advisor Name]

[US Academic Institution]

Clinical Research & Study Design

[Advisor Name]

Regulatory Affairs

IRB Strategy & Compliance

Your Research.Executed WhereIt Matters Most.

The CRO Built forWhere Others Don't Go

End-to-End ClinicalResearch Services

Built for Jamaicaand the Caribbean

The Standards WeHold Ourselves To