Skip to content
Precision for Medicine
Contact Us
clinical trial patient doctor

Global Late Phase CRO

2025 Fierce Biotech CRO Award Winner 

CRO Winner Badge@2x-1

 Phase 2b–3 clinical trials designed for scale, with integrated biomarker strategy, global execution, and regulatory expertise that expedite your path from pivotal data to market.  

350
Phase 2-3 Studies in Oncology & Rare diseases
55
Countries global clinical operations
23
FDA & EMA Approvals in the last decade
5
Specialty Labs across North America and Europe

Your Global Late Phase CRO

Late phase development amplifies risk as trials scale across regions and populations. Our late phase model manages that risk through early alignment and continuous oversight as programs progress toward submission. 

01 Global Trial Execution

Global clinical operations structured for multi‑region Phase 2b and Phase 3 trials, with centralized oversight and local execution where it matters. Feasibility, site activation, and enrollment are coordinated to maintain consistency across regions while accounting for regional regulatory and operational requirements. 

02 Biomarker & Translational Science

Translational science and biomarker strategy integrated into late phase execution to ensure data generated at scale remains interpretable and submission‑ready. Specialty laboratory capabilities support specimen management, biomarker consistency, and data integrity as trials progress across geographies. 

03 Regulatory & Market Readiness

Regulatory strategy embedded throughout late phase execution to align ongoing data generation with submission and market‑readiness requirements. Planning evolves alongside the trial to support efficient NDA and BLA preparation as pivotal studies approach completion. 

Everything Your Pivotal Program Needs, Integrated

Navigate complex Phase 2b-3 trials with scale and end-to-end solutions that propel your therapy towards market readiness. Precision for Medicine is at the forefront of late phase clinical trials, offering scalability, full-service execution, and regulatory readiness to ensure your project's success.

 

  • Global Trial Execution

    Global Trial Execution

    • Global clinical operations structured for Phase 2b and Phase 3 trials across regions where patients can be identified and enrolled.

    • Centralized oversight and local execution support consistent trial delivery while accounting for regional regulatory and operational requirements. 

  • Regulatory Strategy & Submissions

    Regulatory Strategy & Submissions

    • Regulatory support spanning late phase execution, submission planning, and agency interactions.

    • Strategy stays connected to ongoing data generation to support efficient NDA and BLA preparation. 

  • Biomarker & Lab Integration

    Biomarker & Lab Integration

    • Integrated biomarker strategy and specialty laboratory services supporting specimen management, biomarker consistency, and data integrity at scale.

    • Laboratory execution remains aligned with clinical operations as enrollment expands across regions. 

  • Patient Recruitment
    & Retention

    Patient Recruitment
    & Retention

    • Enrollment strategies designed for large, multi‑region cohorts, combining data‑driven feasibility, site engagement, and patient‑centric operational models to support sustained enrollment and minimize disruptions.

Deep Experience in the Indications That Matter to You

  • Explore
    Pivotal oncology trials
    clinical-trial-services

    Oncology CRO

    76% of our trials are in oncology. Phase 2b–3 programs across solid tumors, hematologic malignancies, and immuno-oncology with 160+ biomarker-driven trials and companion diagnostic co-development. 
    Explore
    clinical-trial-services

    Oncology CRO

    76% of our trials are in oncology. Phase 2b–3 programs across solid tumors, hematologic malignancies, and immuno-oncology with 160+ biomarker-driven trials and companion diagnostic co-development. 
    Explore
  • Explore
    Rare diseases
    genomics_analysis

    Rare Disease CRO

    67% of our trials involve rare diseases. We design adaptive pivotal trials for small populations with Orphan Drug Designation and Fast Track Designation support. 
    Explore
    genomics_analysis

    Rare Disease CRO

    67% of our trials involve rare diseases. We design adaptive pivotal trials for small populations with Orphan Drug Designation and Fast Track Designation support. 
    Explore
  • Explore
    GettyImages-1316192297-Doctor_Looking_at_Xray-RET-3
    matchedtissue-blood

    Cell & Gene Therapy

    Pivotal late‑phase studies supporting cell and gene therapies, advanced diagnostics, and companion diagnostics. Strategies that address complex safety profiles, long‑term follow‑up, biomarker‑driven development, and regulatory requirements across the FDA, EMA, and global agencies — supported by integrated lab and clinical operations. 
    Explore
    matchedtissue-blood

    Cell & Gene Therapy

    Pivotal late‑phase studies supporting cell and gene therapies, advanced diagnostics, and companion diagnostics. Strategies that address complex safety profiles, long‑term follow‑up, biomarker‑driven development, and regulatory requirements across the FDA, EMA, and global agencies — supported by integrated lab and clinical operations. 
    Explore
  • Explore
    Img-biologie-cta
    specialty_lab_services

    Autoimmune CRO

    Late phase programs in autoimmune and inflammatory indications using our immune profiling expertise and Epiontis ID epigenetic immune cell phenotyping for patient stratification and treatment response monitoring. 
    Explore
    specialty_lab_services

    Autoimmune CRO

    Late phase programs in autoimmune and inflammatory indications using our immune profiling expertise and Epiontis ID epigenetic immune cell phenotyping for patient stratification and treatment response monitoring. 
    Explore
  • pediatrics
    patient_registration

    Pediatric Clinical Trials

    Pediatric trial design and execution with pediatric designation support and age-appropriate endpoints for confirmatory studies required by FDA and EMA pediatric regulations. 
    patient_registration

    Pediatric Clinical Trials

    Pediatric trial design and execution with pediatric designation support and age-appropriate endpoints for confirmatory studies required by FDA and EMA pediatric regulations. 
  • Advancing Biomarker Strategies for Immuno-Oncology RD with High-Quality Biospecimens_Image_259x160
    central_lab_services

    ADC & Emerging Modality Trials

    Registrational programs for antibody-drug conjugates and targeted therapies with integrated companion diagnostic co-development, biomarker-driven patient selection, and translational endpoints. 
    central_lab_services

    ADC & Emerging Modality Trials

    Registrational programs for antibody-drug conjugates and targeted therapies with integrated companion diagnostic co-development, biomarker-driven patient selection, and translational endpoints. 

Proprietary Tools That Accelerate Your Program 

  • Risk-Based Quality Management
  • Automated Data Transformation for Submissions

  • Clinscope

    When risk-based oversight is reduced to a compliance checkbox, critical signals get missed. Our proprietary Clinscope platform integrates EDC, CTMS, labs, and other study-specific data streams into near real-time dashboards for risk-based quality management, with centralized monitoring workflows driven by 25+ clinical scientists and 50+ pre-built dashboards. Grounded in ICH E6(R3) and E8(R1) guidelines, Clinscope enables proactive signal detection across your pivotal program. 

    Clinical Monitoring_Data Curve

  • Metavate

    Submission delays cost time and resources. Metavate accelerates your path to market with metadata-driven automation, converting clinical data from any source into CDISC-compliant, submission-ready datasets. The result: 60% faster specification creation, 50% faster dataset delivery, and 65% faster Define.XML generation for regulatory-ready packages. 

    Data standards_Legacy studies

Data Oversight from Collection Through Submission

See How We’ve Helped Programs Like Yours

  • Read Case Study

    Case Study - ONCOLOGY

    Rescue of a Global Phase 3 Trial in Multiple Myeloma

    A global Phase 3 trial in relapsed multiple myeloma faced operational and data quality risks during expansion. Read the full case study to explore how Precision teams not only stabilized the study but also met complete enrollment one month ahead of target while preserving primary endpoint integrity. 
    • 150+
      sites
    • 20+
      countries
    Read Case Study
  • Read Case Study

    Case Study - ONCOLOGY

    Navigating Complexity: Rescuing a Biomarker-Driven Breast Cancer Trial

    A multinational Phase 2–3 breast cancer trial evaluating a targeted therapy in a genetically defined patient population faced slow enrollment and operational fragmentation. Precision was engaged to rescue and scale the study, driving renewed momentum while preserving scientific rigor and data integrity.
    • 430+
      patients enrolled
    • 140+
      sites globally
    Read Case Study
  • Read Case Study

    Case Study - ONCOLOGY

    Phase 3 Prostate Cancer Case Study: Radiopharm Imaging at Scale

    This Phase 3 PSMA-targeted imaging trial in prostate cancer, ran across the U.S. and Canada, required on-time administration of a short-lived radiopharmaceutical within hours of delivery.  Read how this study scaled while maintaining dose-on-time compliance, zero site shutdowns, and robust imaging data quality.

    • 380+
      participants
    • 0
      Data quality issues
    Read Case Study

Related Capabilities and Service Areas 

  • Explore
    Global regulatory affairs
    global_cro_clinical_trials

    Global CRO Services

    Experts in 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 
    Explore
    global_cro_clinical_trials

    Global CRO Services

    Experts in 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 
    Explore
  • Explore
    Biomarker-Driven Clinical Trials in Oncology - Enrichment, Stratification, All-Comers & Basket
    sample_analysis

    Early Phase CRO

    FIH, Phase 1, and Phase 1-2 trials with integrated biomarker strategy and regulatory expertise. These are the upstream programs that feed into your pivotal studies.
    Explore
    sample_analysis

    Early Phase CRO

    FIH, Phase 1, and Phase 1-2 trials with integrated biomarker strategy and regulatory expertise. These are the upstream programs that feed into your pivotal studies.
    Explore
  • Explore
    Tumor_data
    informatics

    Centralized Monitoring

    Risk-based quality management (RBQM) powered by Clinscope, with 50+ pre-built dashboards, therapeutic-specific assessment standards, and a Clinical Science team providing lifecycle RBQM from study start-up through database lock. 
    Explore
    informatics

    Centralized Monitoring

    Risk-based quality management (RBQM) powered by Clinscope, with 50+ pre-built dashboards, therapeutic-specific assessment standards, and a Clinical Science team providing lifecycle RBQM from study start-up through database lock. 
    Explore
  • Explore
    Hero_Stats programming
    online_management_tracking

    Biostatistics

    Biostatistical consulting, clinical trial design, statistical programming, PK/PD analysis, and DMC support. Metavate accelerates submissions with automated, metadata-driven data transformation for CDISC-compliant SDTM/ADaM datasets and eCTD packages. 
    Explore
    online_management_tracking

    Biostatistics

    Biostatistical consulting, clinical trial design, statistical programming, PK/PD analysis, and DMC support. Metavate accelerates submissions with automated, metadata-driven data transformation for CDISC-compliant SDTM/ADaM datasets and eCTD packages. 
    Explore

Frequently Asked Questions

How do you select sites for global Phase 3 trials?

Site selection for global Phase 3 trials requires balancing enrollment potential, regulatory timelines, and operational feasibility across regions. Our Precision Site Network of academic centers gives us access to specialized patient populations, and we pair that with data-driven feasibility assessments that model enrollment curves by country and site. Our experience executing 55% of trials internationally across 55+ countries gives us direct insight into site performance by geography and therapeutic area. 

What experience does Precision have in late‑phase clinical development?

Precision for Medicine supports Phase 2b, Phase 2-3, and Phase 3 clinical trials designed to confirm efficacy, characterize safety, and support regulatory submissions. Teams have executed hundreds of late‑phase studies across oncology, rare disease, and other complex indications, with experience managing global enrollment, long‑term safety follow‑up, and inspection‑ready documentation at scale.

Can you rescue a stalled Phase 3 trial?

Yes. We have extensive experience in trial rescue, including rapid CRO transitions, site re-activation, and enrollment recovery. Our functional service provider (FSP) model allows us to embed teams within your existing infrastructure for targeted support, whether that means taking over enrollment in specific regions, managing safety reporting, or providing biostatistical analysis for interim reviews.  

What therapeutic areas does Precision support in late‑phase development?

Precision’s deepest late‑phase experience is in oncology and rare diseases, with additional expertise in autoimmune disorders, cell and gene therapies, and other complex indications. Late‑phase teams are staffed based on therapeutic complexity and risk profile rather than a one‑size‑fits‑all resourcing model.

What regulatory submission support do you provide?

Our regulatory affairs team supports the full submission lifecycle: NDA/BLA preparation, clinical study report authoring, ISS/ISE analyses, and post-approval commitments. We have supported 23 FDA and EMA approvals in the last decade, including various fast track and breakthrough designations. Metavate accelerates the data transformation process, delivering submission-ready CDISC-compliant datasets. 

Does Precision support registrational and pivotal late‑phase trials?

Yes. Precision supports registrational and other pivotal late‑phase trials intended to support FDA, EMA, and global regulatory submissions. These programs are executed with the operational rigor, documentation quality, and regulatory alignment required for marketing authorization decisions and agency review. 

Do you support decentralized and hybrid trial designs?

Yes. Our decentralized clinical trial (DCT) capabilities include remote patient monitoring, eConsent, direct-to-patient drug shipment, and home health nursing visits. Hybrid designs combine traditional site visits with decentralized elements to improve patient retention and expand geographic reach, particularly valuable for late phase trials recruiting large, diverse populations. 

How are biomarkers and translational science handled in late‑phase trials?

In late‑phase programs, biomarker and translational strategies are integrated to ensure consistency, interpretability, and submission readiness at scale. Biomarker execution is aligned with clinical operations so specimen handling, laboratory workflows, and data generation remain reliable across regions and sites as patient numbers increase.

Curated Insights 

 All Resources
Loading...
Loading...