Clinical Trial Diagnostic Services

    The Diagnostic Partner
    Built for CROs.

    KoHealthLabs provides integrated central lab and radiology services for Phase I–IV clinical trials — delivering a single, structured data bundle that simplifies vendor management and accelerates regulatory submissions.

    Core Capabilities

    Everything Your Trial Needs,
    Under One Roof

    Central Laboratory

    CLIA-certified central lab with CAP accreditation. 100+ analytes processed with chain-of-custody tracking from draw to result.

    Integrated Radiology

    Board-certified radiologists providing site reads and independent central review for MRI, CT, PET, and X-ray endpoints.

    Unified Data Bundle

    Lab and imaging data delivered together in SDTM-ready formats — eliminating reconciliation work between separate vendors.

    Regulatory Compliance

    21 CFR Part 11-compliant systems. Full audit trails, electronic signatures, and GLP/GCP-aligned SOPs ready for FDA, EMA, and PMDA submissions.

    Rapid Turnaround

    Stat processing with 24–48 hour turnaround for critical safety labs. Routine panels reported within 72 hours with automated alerts.

    Dedicated Project Team

    A single dedicated project manager coordinates your protocol-specific requirements, site onboarding, and data delivery schedule.

    Trial Phase Support

    Phase I to IV —
    We Go the Distance

    Phase ISafety & Dose-Finding

    PK/PD sampling, safety labs, hematology, clinical chemistry, and urinalysis with rapid turnaround for dose-escalation decisions.

    Complete Metabolic PanelCBC with differentialCoagulation PanelPK Blood DrawsUrinalysis
    Phase IIEfficacy & Biomarker Exploration

    Exploratory biomarker panels, companion diagnostics, and imaging endpoints to support proof-of-concept decisions.

    Biomarker PanelsCompanion DiagnosticsMRI / CT ImagingProteomicsMetabolomics
    Phase IIIConfirmatory Efficacy & Safety

    High-volume central lab processing, multi-site harmonization, and real-time data quality monitoring for pivotal trials.

    Central Lab ServicesMulti-site HarmonizationReal-time QC MonitoringRadiology ReadsIndependent Review
    Phase IVPost-Market Surveillance

    Long-term safety follow-up, pharmacovigilance lab support, and registry-grade data collection at scale.

    Pharmacovigilance LabsLong-term Follow-upSafety Registry SupportComparative EffectivenessReal-World Evidence
    Our Process

    From Contract to
    Clean Data Delivery

    01

    Protocol Review

    We review your protocol and SAP to design a specimen management and data delivery plan aligned to your endpoints.

    02

    Site Onboarding

    Lab kits, shipping logistics, and site staff training — delivered within 3 weeks of contract execution.

    03

    Continuous Monitoring

    Real-time dashboards for data completeness, query rates, and site performance throughout enrollment.

    04

    Regulatory Package

    Clean, submission-ready data files delivered with audit trails, validation reports, and data transfer agreements.

    Therapeutic Expertise

    40+ Therapeutic Areas
    Covered

    OncologyCardiologyNeurologyImmunologyEndocrinologyRare DiseasesInfectious DiseaseRespiratoryRenalGastroenterologyDermatologyOphthalmologyHematologyRheumatologyMetabolic Disease

    Let's Review Your Protocol

    Our clinical operations team will assess your diagnostic requirements and provide a customized service proposal within 5 business days.

    Schedule a Consultation

    Ready to get started?

    How can we help you today?

    Order a Test

    Submit a test order instantly.

    Schedule a Pickup

    Request a courier to pick up specimens.

    Request a Phlebotomist

    Schedule a mobile phlebotomist.

    Become a Provider

    Set up your provider account.