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Specialty and Central Lab Services in Europe

Comprehensive central and specialty lab services: biomarker assays for European clinical trials

As a global contract research organization, we understand the unique needs and challenges of clinical development. That’s why we’ve built a robust infrastructure of central and specialty labs across Europe, including our state-of-the-art facilities in Germany and the UK. Our European labs are equipped to provide comprehensive services, from sample processing and kitting to advanced biomarker assays to support your needs from preclinical stages through to completion.

European Service Offering Overview

Precisely navigating the complexities of clinical trials, our European team provides specialized and central lab services, biospecimens, and regulatory consulting services tailored to accelerate therapeutic and diagnostic development.

  • Central Lab Services

    • Clinical Specimen Kitting
    • Biorepository and Sample Storage
    • PBMC Sample Processing
    • BMMC Sample Processing
    • Biopsy Processing
  • Immune Monitoring

    • Flow Cytometry
      • Immunophenotyping
      • Phospho Flow
      • Receptor Occupancy
      • Tetramer Flow Assays
      • Cell Sorting
    • Epiontis ID® - Proprietary Immune Cell Quantification Platform
    • ELISpot/FluoroSpot
  • Tissue Profiling & Pathology Services

    • Immunohistochemistry (IHC)
    • Multiplex Immunofluorescence (mIF)
    • In Situ Hybridization (ISH)
    • Proximity Ligation Assays (PLA)
    • Digital Image Analysis
    • Cell-based Assays
    • Cellular Imaging
    • H&E, Special Stains
    • GLP Tissue Cross-Reactivity
    • Tissue Microarray (TMA) Design and Construction
  • Bioanalytical Testing

    • Immunogenicity Testing
    • PK Assays
    • ADA Assays
    • Meso Scale Discovery (MSD) Assays
    • ELISA
    • Western blotting
  • Genomics Services

    • ddPCR
    • Next Generation Sequencing (NGS)
    • PCR
    • qRT-PCR
    • PDAC KRAS Assay
  • Regulatory Consulting

    • Global Regulatory Strategy
    • Annex XIV and Local Ethics Committee Submissions
    • Meetings with Regulatory Agencies
    • Analytical Validation for Clinical Trial Assays
    • IVDR CE Mark and UKCA Mark
    • Post-Market Surveillance
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Specialty lab services in Berlin, Germany

Precision’s accredited lab in Berlin, Germany, offers a comprehensive suite of services. Specifically equipped to meet the unique needs of clinical development, this lab provides tailored central lab services and specialized clinical immune monitoring. A standout feature of our Berlin lab is that it houses Precision’s proprietary Epiontis ID® technology. The Berlin lab also offers the PDAC KRAS Assay as an in house IVD test in alignment with Article 5(5) of EU IVD Regulation (2017/746).

Specialty
Central Lab Service, Clinical Immune Monitoring, Bioanalytical Testing, Genomics

Certifications/Accreditations
ISO 17025, GCP/ICH

Specialty lab services in Royston, United Kingdom

Located in Royston, UK, our accredited lab offers a wide array of services. This lab, specifically equipped for tissue profiling and pathology services, delivers a range of capabilities from IHC to genomics, with a distinct emphasis on target and biomarker validation. A significant aspect of Precision’s Royston lab is its offering of various assay development and validation services.

Specialties
Discovery Biology, Preclinical and Clinical Target and Biomarker Assays, Tissue Profiling and Pathology Services

Certifications/Accreditations
GLP, GCLP (GCP), HTA-licensed

Multiple European Sample Processing Locations Ensure Rapid and Consistent Processing and Analysis

Precision’s end-to-end solution offers real-time processing in more than 55 countries. Our biomarker assay services in Europe feature custom assay and kit development capabilities, and state-of-the-art biobanking facilities for secure storage, management, and distribution of samples for future use – all helping researchers ensure high-quality samples and optimize the value of their study data.

Clinical Reach

Transforming Science into Solutions through Integrated Services

At Precision, we’ve crafted a specialized suite to tackle the multifaceted challenges of translational research head-on. Our comprehensive solutions for translational and biomarker science start with biospecimens and span a range of laboratory services, from biomarker identification to clinical immune monitoring, companion diagnostics development and more. This ensures seamless support for every phase of your therapeutic development journey, from preclinical testing through to commercialization.

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Translational and Biomarker Sciences: Enabling Breakthroughs

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Translational and Biomarker Sciences: Enabling Breakthroughs

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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778874, hs_child_table_id=0, hs_updated_at=1714461729999, hs_published_at=1736962071401, description=Kennon Daniels is a scientific and regulatory in vitro diagnostic authority, specializing in the development of US regulatory strategies and FDA marketing submissions for IVD assays and instruments. Her expertise spans all aspects of product development, analytical and clinical trial protocol designs, Q-Submissions, IDEs, de novos, 510(k)s, and pre-market approval platforms., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Kennon%20Daniels.webp',altText='Kennon Daniels',fileId=165893120790}, linkedin=https://www.linkedin.com/in/kennon-daniels-ph-d-84a90b6, hs_name=, hs_path=, lastname=Daniels, hs_initial_published_at=1716212769184, hs_created_at=1709645745105, hs_is_edited=false, hs_deleted_at=0, name=Kennon, job=, slug=kennon-daniels, email=, hs_updated_by_user_id=26433386}, second={hs_id=159488778882, hs_child_table_id=0, hs_updated_at=1714461102447, hs_published_at=1736962071401, description=Dr. Curnutte has more than ten years of research and regulatory affairs experience focused on in vitro diagnostics (IVDs). She has held regulatory positions at both device and pharmaceutical companies, during which she led seven U.S. and ex-U.S. companion diagnostic registrations. She has extensive expertise in CDx development and clinical trial integration, IVD product development, next-generation sequencing technologies, and translation of U.S. regulatory strategy to major markets., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Margaret%20Curnutte.webp',altText='Margaret Curnutte',fileId=165892782094}, linkedin=https://www.linkedin.com/in/margaret-curnutte-93558913, hs_name=, hs_path=, lastname=Curnutte, hs_initial_published_at=1716212769184, hs_created_at=1709645745113, hs_is_edited=false, hs_deleted_at=0, name=Margaret, job=, slug=margaret-curnutte, email=, hs_updated_by_user_id=26433386}, third={}})
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    has third author: false, (SizeLimitingPyMap: {main={hs_id=159488778875, hs_child_table_id=0, hs_updated_at=1716454216458, hs_published_at=1736962071401, description=Pharma industry veteran and expert at biomarker-driven clinical trial design and execution. Leader of biomarker and drug development programs for pharmaceutical and diagnostics companies, as well as the National Institutes of Health. Spearheaded the discovery of pharmacodynamic biomarkers and novel targets for inflammatory disease therapy., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Deb%20Phippard.webp',altText='Deb Phippard',fileId=165892372605}, linkedin=https://www.linkedin.com/in/deb-phippard-103b54, team=[{id=163072475007, name='Precision for Medicine Leadership'}], hs_name=, hs_path=, lastname=Phippard, PhD, hs_initial_published_at=1716212769184, hs_created_at=1709645745106, hs_is_edited=false, hs_deleted_at=0, name=Deborah, job= Chief Scientific Officer, slug=deborah-phippard, email=, hs_updated_by_user_id=26433386}, second={hs_id=159488778874, hs_child_table_id=0, hs_updated_at=1714461729999, hs_published_at=1736962071401, description=Kennon Daniels is a scientific and regulatory in vitro diagnostic authority, specializing in the development of US regulatory strategies and FDA marketing submissions for IVD assays and instruments. Her expertise spans all aspects of product development, analytical and clinical trial protocol designs, Q-Submissions, IDEs, de novos, 510(k)s, and pre-market approval platforms., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Kennon%20Daniels.webp',altText='Kennon Daniels',fileId=165893120790}, linkedin=https://www.linkedin.com/in/kennon-daniels-ph-d-84a90b6, hs_name=, hs_path=, lastname=Daniels, hs_initial_published_at=1716212769184, hs_created_at=1709645745105, hs_is_edited=false, hs_deleted_at=0, name=Kennon, job=, slug=kennon-daniels, email=, hs_updated_by_user_id=26433386}, third={hs_id=159488778889, hs_child_table_id=0, hs_updated_at=1714461111815, hs_published_at=1736962071401, description=Travis Harrison, PhD, is Vice President of Diagnostic Development at Precision for Medicine. He brings more than 20 years of bioanalytical assay experience to the Precision team with expertise in ligand-binding and cell-based assays.  Travis has experience supporting clinical and nonclinical studies for a broad range of indications, with an emphasis on diagnostic assays to evaluate immune responses to gene therapies., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Travis%20Harrison.webp',altText='Travis Harrison',fileId=165893006481}, linkedin=https://www.linkedin.com/in/travis-harrison-phd-6108852/, hs_name=, hs_path=, lastname=Harrison, hs_initial_published_at=1716212769184, hs_created_at=1709645745120, hs_is_edited=false, hs_deleted_at=0, name=Travis, job=, slug=travis-harrison, email=, hs_updated_by_user_id=26433386}})
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