US-Based Clinical Research Organization

Your Research.
Executed Where
It Matters Most.

Prescriptive Research is a US-based CRO that works with research sites and sponsors across the United States. We help sites get pharmacy and inspection readiness right, and we give sponsors GCP-grade study execution under US standards. We also operate in the Caribbean, with local counsel and established regulatory relationships on the ground, so sponsors can reach underrepresented patient populations while contracting with a single accountable US entity.

Pharmacy and inspection readiness for US research sites
Protocol, monitoring, and data support for sponsors
Caribbean patient access through one US contract
GCP standards applied to every study by default
Our Services Start a Conversation For US Research Sites
Who We Serve
US Research Sites and Sponsors
Therapeutic Focus
Cardiovascular, Rare Disease & Specialty Therapeutics
Study Types
Phase 2 to 4, Real-World Evidence, Post-Approval
Where We Operate
United States and the Caribbean
GCP Compliant 21 CFR 312.120 IRB Oversight RWE Studies Site Readiness
US-Based & Incorporated
GCP-Compliant by Default
FDA 21 CFR 312.120 Expertise
US Sites and Sponsors
Caribbean Research Presence
Why Work With Us

Built for Rigor,
Wherever the Study Runs

Prescriptive Research brings the same standards to every study, whether it runs at a US site or in the Caribbean. For US sites, that means pharmacy and investigational product practices that hold up to monitoring and inspection.

For sponsors, it means GCP-grade execution, clear contracts, and access to patient populations that are underrepresented in current data. Your program is protected 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 get every regulatory requirement confirmed in writing, with no reliance on verbal assurances. In complex markets, certainty is a deliverable, not a given.

3
GCP from Day One

We apply conservative GCP standards by default, as protection rather than overhead. 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 alongside official approvals. Because the independent path is already built, uncertainty in emerging markets does not become a problem for your timeline.

What We Do

Full-Service
Clinical Research

From the first regulatory strategy conversation to the final sponsor deliverable, Prescriptive Research manages each phase of the study, so you can focus on your science.

01
Regulatory Strategy & Navigation

We map the regulatory landscape before your study begins. We separate mandatory requirements from best-practice guidance, get written confirmations, and build 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 to 4 trials and real-world evidence studies. We build in the endpoints, controls, and documentation standards that let your data serve more than one purpose, including regulatory submissions you may not be planning yet.

03
Site Activation & Clinical Monitoring

Site qualification, investigator onboarding, staff training, and ongoing monitoring for sites in the US and the Caribbean. We bring each site up to international standards without cutting corners on 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 start, so there is no ambiguity and no dispute later.

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. The result is a complete path from data to market access.

Our Caribbean Presence

How We Operate
in the Caribbean

The Caribbean is one of the most clinically significant untapped markets in the world. It has distinct genetic profiles, high rates of cardiovascular and metabolic disease, and patient populations almost entirely absent from global clinical data. Yet it remains largely out of reach for sponsors without infrastructure and regulatory expertise on the ground.

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

Drug registration, IRB strategy, and Ministry of Health engagement frameworks are already in place, which removes months of groundwork from your timeline.

Populations Underrepresented in Global Data

Caribbean populations carry distinct genetic profiles that most existing trial data does not capture. That gap is a real scientific and commercial opportunity for sponsors.

Formulary & Market Access Pipeline

Studies run through Prescriptive Research generate the local data needed for national formulary inclusion, carrying value from the trial through to patient access.

Distinct
Genetic Profiles

Caribbean populations carry hereditary disease variants significantly underrepresented in existing global clinical trial data, which creates 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, so your data meets FDA standards wherever it is collected.

Proven
Operational Frameworks in Place

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

For US Research Sites

Research Site Services

Pharmacy and investigational product support for independent research sites and physician practices running clinical trials. Many monitoring findings at smaller sites come back to the same place: how study drug is received, stored, dispensed, and accounted for. Our founder has more than 15 years in hospital pharmacy, trial site execution, and biotech clinical supply, and we help sites get this part right before a monitor or auditor looks at it.

Investigational Product SOP Package

A ready-to-use set of pharmacy SOPs covering receipt, storage, temperature monitoring and excursions, dispensing, accountability, returns and destruction, and unblinded pharmacist workflows. Tailored to your site and delivered with templates and logs.

Site Pharmacy Setup

For sites taking on their first studies or a new therapeutic area. We review your storage, equipment, and workflow, adapt SOPs to how your team actually works, and train your staff.

Mock Inspection

A pharmacy-focused audit against ICH E6(R3) and 21 CFR 312.62 before a sponsor audit, monitoring visit, or FDA inspection. You receive a written findings report with prioritized fixes.

Ongoing Pharmacy Oversight

Monthly support for sites without a pharmacist on staff. This includes accountability reviews, excursion assessments, and a pharmacist available when questions come up.

How it works

  1. A free 20-minute readiness call about your studies and current setup.
  2. A fixed-fee proposal, with no open-ended hourly billing.
  3. Delivery on your timeline, done remotely with site visits as needed.

Who we work with

Independent research sites, physician practices with research programs, and site networks opening new locations.

Book a Readiness Call

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. This protects your data against future scrutiny and gives it the most regulatory value possible.

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 are 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 oversees 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

Tell Us About
Your Study

If you are a sponsor exploring Caribbean or emerging market research, an academic institution seeking a compliant operational partner, a clinical site interested in international studies, or a US research site looking for pharmacy and inspection readiness support, we would like to hear from you.

Headquarters
United States
Response Time
Within 2 business days

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