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CRO global overview

Global CRO Services

2025 Fierce Biotech CRO Award Winner 

CRO Winner Badge@2x-1

 Partner with a global contract research organization built to manage multi‑region clinical development across North America, Europe, Latin America, and Asia‑Pacific, integrating clinical operations, regulatory strategy, and translational expertise from planning through global execution. 

600
Projects across all development phases
2500
Lab Projects across the US and Europe
3500
Employees globally
25
Years conducting global trials

A Different Kind of CRO

Global programs break when execution, data, and regulatory strategy fall out of alignment across regions. Precision for Medicine is a global CRO built to prevent those gaps by integrating global clinical operations, regulatory strategy, and translational expertise into a single model that supports decisions and keeps submissions coordinated.
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01 Global Clinical Operations

Run your trial where your patients are. Our operational infrastructure spans 55+ countries with regional teams across the Americas, Europe, and Asia-Pacific who combine centralized oversight with local market knowledge. 

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02 Global Regulatory Strategy

Navigate multi-regional regulatory pathways with coordinated submissions across FDA, EMA, and international agencies. From Pre-IND/CTA planning through NDA/BLA preparation, our regulatory affairs team aligns your strategy across every jurisdiction. 

Precision Lab e-Portal

03 Translational Expertise

Biomarker intelligence informs our approach to trial design, patient selection, and endpoint strategy. We connect translational insights directly to clinical execution, regulatory submissions, and commercialization readiness. 

End-to-End Global CRO Services

From first-in-human through post-approval, every capability operates within a single coordinated model, drawing on 600+ projects completed across all development phases. With expertise in over 50 countries, our local specialists provide invaluable insights and regulatory compliance, ensuring seamless execution across borders.

Our global scale, combined with precise local knowledge, accelerates the progress of your clinical trials with efficiency and expertise. 

 

 

  • Clinical Development Strategy

    Clinical Development Strategy

    Clinical development planning for global success

    Unlock the full potential of your clinical trials with our bespoke Clinical Development Strategy, designed to navigate complexities and accelerate success. 

  • Full-Service CRO

    Full-Service CRO

    Global reach, local precision

    Experience the seamless integration of comprehensive trial management with our Full-Service CRO, where every detail is expertly managed to drive your study's success. 

  • FSP Services

    FSP Services

    Agile, scalable delivery expertise

    Enhance your clinical trial's efficiency with Precision’s Functional Service Provider (FSP) solutions, offering specialized support tailored to your project's unique needs. 

Find the Right Expertise for Your Program

Whether you're planning a first-in-human study, scaling a global pivotal trial, or navigating an orphan indication, we have specialized teams built for your stage and therapeutic area.

Global expertise across phases and therapeutic areas

Experience Across the Indications and Modalities Where Execution Matters Most 

Like you, we understand there's a patient behind every data point. Our teams bring experience across complex indications and advanced modalities where scientific nuance, operational scale, and regulatory rigor intersect. 

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    Global CRO services
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    Oncology & Immuno-Oncology

    76% of our trials are in oncology. This experience supporting global oncology programs spans solid tumors, hematologic malignancies, and immuno‑oncology. Programs integrate biomarker‑driven strategies, complex endpoint requirements, and multi‑region execution to support registrational outcomes. 
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    clinical-trial-services

    Oncology & Immuno-Oncology

    76% of our trials are in oncology. This experience supporting global oncology programs spans solid tumors, hematologic malignancies, and immuno‑oncology. Programs integrate biomarker‑driven strategies, complex endpoint requirements, and multi‑region execution to support registrational outcomes. 
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    Central and specialty lab services
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    Rare & Orphan Diseases

    67% of our trials involve rare diseases. Expertise includes small-population trial design, natural history studies, and regulatory pathway support, including Orphan Drug Designation and Fast Track Designation support. 
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    specialty-lab-services

    Rare & Orphan Diseases

    67% of our trials involve rare diseases. Expertise includes small-population trial design, natural history studies, and regulatory pathway support, including Orphan Drug Designation and Fast Track Designation support. 
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    Regulatory consulting services
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    Autoimmune & Inflammatory

    Clinical development expertise across autoimmune and inflammatory conditions, supporting global enrollment, adaptive designs, and biomarker strategies aligned to heterogeneous disease presentation and treatment response. 

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    protein_molecule

    Autoimmune & Inflammatory

    Clinical development expertise across autoimmune and inflammatory conditions, supporting global enrollment, adaptive designs, and biomarker strategies aligned to heterogeneous disease presentation and treatment response. 

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    Advanced Modalities

    Global development experience across advanced therapeutic modalities, including cell therapy, gene therapy, and other precision‑based approaches. Programs account for safety profiles, long‑term follow‑up requirements, and evolving regulatory expectations across regions. 
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    genomics_analysis

    Advanced Modalities

    Global development experience across advanced therapeutic modalities, including cell therapy, gene therapy, and other precision‑based approaches. Programs account for safety profiles, long‑term follow‑up requirements, and evolving regulatory expectations across regions. 
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  • Global Reach, Regulatory Expertise, and and Innovative Trial Approaches

    Running a successful global program requires more than sites in multiple countries. It takes regional regulatory knowledge, innovative trial designs, and technology that keeps your team in control across every market. 

  • Global regulatory affairs

    Global Reach

    Our operational infrastructure spans 55+ countries with regional teams across the Americas, Europe, and Asia-Pacific. The Precision Site Network provides access to academic medical centers for specialized patient populations, particularly in oncology and rare diseases. 
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    Americas

    20 offices, 2,350 experts, and Precision labs with 50+ global centers of excellence supporting clinical operations across North and South America.
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    Europe

    10 offices, 700 experts, and Precision labs with regulatory expertise across CTR (via CTIS) and non-CTR EU pathways, plus the Precision Site Network for academic access.
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    Asia-Pacific

    500 clinical trial experts across 8 locations with sample processing facilities and expanding operations in Japan, Australia, China, Taiwan, Singapore, and India.
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See How We've Helped Programs Like Yours

  • Read Case Study

    Case Study - EARLY PHASE DEVELOPMENT

    Global Phase 1–2 ROS1 Inhibitor Case Study in NSCLC

    Discover how Precision for Medicine achieved zero data issues across 60+ global sites in a first-in-human Phase 1–2 ROS1 inhibitor trial for NSCLC—highlighting a model of operational excellence, rapid site activation, and seamless phase transition.

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  • Read Case Study

    Case Study - RARE DISEASE

    Rare Liver Disease RNAi Trial

    RNAi trial in AATD overcame blinded data and COVID delays across 8 countries. Precision delivered two on-time interim analyses with phased updates.

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  • Read Case Study

    Case Study - EARLY PHASE DEVELOPMENT

    Swift Stabilization in Phase 1 Solid Tumor Rescue

    White-glove teamwork rescued a Phase 1 solid tumor trial—delivering on-time milestones and earning a second study award.

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Related Services & Capabilities 

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    clinical-trial-services

    Specialty Lab Services

    5 specialty labs across North America and Europe supporting translational biomarker analysis, immune profiling, and companion diagnostic development. 
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    clinical-trial-services

    Specialty Lab Services

    5 specialty labs across North America and Europe supporting translational biomarker analysis, immune profiling, and companion diagnostic development. 
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    Regulatory Strategy Consulting_Hero
    clinical_trial_support

    Regulatory Consulting

    Multi-regional regulatory strategy, agency meeting preparation, and submission support across FDA, EMA, and international agencies for drug, biologic, and device programs.
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    clinical_trial_support

    Regulatory Consulting

    Multi-regional regulatory strategy, agency meeting preparation, and submission support across FDA, EMA, and international agencies for drug, biologic, and device programs.
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    protein_molecule

    Commercial Biospecimens

    Global biospecimen logistics, specimen management, and biobanking services with 35M+ specimens managed across 12 strategic processing locations on 5 continents. 

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    protein_molecule

    Commercial Biospecimens

    Global biospecimen logistics, specimen management, and biobanking services with 35M+ specimens managed across 12 strategic processing locations on 5 continents. 

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Insights from Our Experts 

Explore Our Blog
Read: The Collaborative CRO Partnership Model: Amplifying Your Team The Collaborative CRO Partnership Model: Amplifying Your Team

Clinical Trials

The Collaborative CRO Partnership Model: Amplifying Your Team

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    Alexis Hobbins-White
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Read: What the EMA–FDA AI Principles Really Mean for Clinical Development & Regulatory Affairs What the EMA–FDA AI Principles Really Mean for Clinical Development & Regulatory Affairs

Clinical Trials - Regulatory

What the EMA–FDA AI Principles Really Mean for Clinical Development & Regulatory Affairs

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  • John M. avatar Nicholas R. avatar Rosamund R. avatar

  • John M.

    Nicholas R.

    Rosamund R.
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Read: Hope Through Access: Inside the Partnership Bringing Novel Cancer Therapies to Patients Worldwide Hope Through Access: Inside the Partnership Bringing Novel Cancer Therapies to Patients Worldwide

Clinical Trials - Oncology

Hope Through Access: Inside the Partnership Bringing Novel Cancer Therapies to Patients Worldwide

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  • Rob Maiale avatar

    Rob Maiale
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Frequently Asked Questions

What makes Precision for Medicine different from other global CROs?

Many global CROs scale by layering regions onto disconnected systems. Precision was built to operate globally from the start, aligning clinical operations, translational science, and regulatory strategy within a single execution model. This integration reduces handoffs, limits regional fragmentation, and keeps global programs aligned from early planning through submission.

How does Precision manage consistency across multi‑region clinical trials?

Precision combines centralized program oversight with experienced regional teams across North America, Europe, Latin America, and Asia‑Pacific. Global standards govern execution and data quality, while local experts adapt to regional regulatory, operational, and site‑level realities to keep trials moving without compromising consistency.

What global regulatory expertise does Precision provide?

Precision supports coordinated global regulatory strategies across FDA, EMA, and international health authorities. Regulatory planning begins early, aligning pre‑IND or CTA activities with downstream submission goals so that regional requirements, timelines, and data expectations remain synchronized throughout development.

How does translational science support global trial execution?

Biomarker and translational insights are directly connected to clinical trial design, patient selection, and endpoint strategy. This approach strengthens early decision‑making and ensures that biological insights are carried cleanly through global execution, regulatory submissions, and commercialization planning.


What types of sponsors and programs benefit most from a global CRO model?

Global execution is especially critical for programs in oncology, rare and orphan diseases, and advanced modalities where patient populations are limited and regulatory complexity is high. Sponsors running multi‑region trials or planning for global submission benefit most from an integrated CRO model that reduces operational and regulatory risk.


Does Precision offer both full‑service and FSP engagement models globally?

Yes. Sponsors can engage Precision as a full‑service global CRO or through FSP models that embed functional experts within sponsor teams. Both models operate within the same global infrastructure and quality framework, allowing flexibility without sacrificing oversight or execution standards.


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