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Eurofins Central Laboratory

6 Orders Completed
Lancaster, Pennsylvania, US

About Eurofins Central Laboratory

Divison of: Eurofins Group

At Eurofins Central Laboratory, we are the End-to-End solution to the BioPharma industry! With our four standardized, wholly-owned global locations [US, Netherlands, Singapore, China] and a back office in India, we provide CAP/CLIA certified... Show more »

At Eurofins Central Laboratory, we are the End-to-End solution to the BioPharma industry! With our four standardized, wholly-owned global locations [US, Netherlands, Singapore, China] and a back office in India, we provide CAP/CLIA certified analytical services in both a GCP & GLP environment. This allows us to combine safety and efficacy analysis with Biomarker Services embedded within one laboratory, introducing cost efficiencies into Sponsor study budgets, and increasing specimen integrity by reducing unnecessary transport.

Reliable, high-quality laboratory data is pivotal to the success of clinical trials. It’s the RESULTS THAT MATTER. Since laboratory testing is our sole focus, we go above and beyond to provide an array of services to ensure that any clinical trial sample is collected, transported, managed, analyzed, reported and stored to meet the objectives and purpose of each study. We are dedicated to providing the most cost effective and efficient solutions to pharmaceutical and biotech companies, and CROs alike.

What differentiates Eurofins from the rest? Innovation. Whether that is our specimen visibility tool, EzRF (web-based requisition), our home-based, virtual trial patient specimen collection kits or our mobile laboratory technician service for standardized CAP certified on-site analysis of rapid analytical TAT requirements (PBMC, semen analysis, virology specimen processing), Eurofins Central Laboratory is your analytical solution for Phase 1 to 4 clinical trials.

  1. Eurofins Central Laboratory - Lancaster, Pennsylvania (USA)
    Provides full-service Central Laboratory Operations, covering North/Central/South America.
  2. Eurofins Central Laboratory - Breda, The Netherlands
    Provides full-service Central Laboratory Operations, covering Europe/Middle East/Africa.
  3. Eurofins Central Laboratory - Singapore
    Provides full-service Central Laboratory Operations, covering Asia-Pacific region.
  4. Eurofins Central Laboratory - Shanghai
    Provides full-service Central Laboratory Operations, covering China.
  5. Eurofins Central Laboratory - India
    Provides Data Management, Data Analytics, Investigator Services, System development; support to all global locations.

Website: Eurofins Central Laboratory

Eurofins Central Laboratory is a member of the Eurofins BioPharma Services division of Eurofins Scientific, a full-service global organization with dedicated testing facilities for Early Clinical Development, Central Laboratory Services, Bioanalytical Services, Virology, and Immunology Testing Services, Anatomic Pathology and Genomics Services. As a division of the Eurofins Scientific Group, our sole and only focus is clinical laboratory analysis. We deploy 7 wholly-owned dedicated testing facilities for Central Laboratory Services and both Large and Small Molecule Bioanalytical Services. With €3,781.1 million in annual revenues [2018], over 45,000 employees in 800 laboratories across 47 countries, a portfolio of over 200,000 analytical methods and over 400,000,000 tests performed annually, Eurofins Scientific [or Eurofins Group] is a world leader in laboratory science, providing a unique range of analytical testing services to the pharmaceutical, food, environment and consumer products industries and to governments.

With Eurofins Central Laboratory acting as the hub, in a hub and spoke model, our Customers have access to all specialized divisions within the Eurofins BioPharma Services Group. This includes standalone divisions focused on Anatomical Pathology, Genomics, Virology and Immunology Testing Services, Bioanalytical Services and the Eurofins Phase 1 unit. In support of full service, central laboratory contracts, Eurofins provides access to all these units of specialization with single source contracting and invoicing.

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Certifications & Qualifications

CLIA/CAP GCLP GCP GLP ISO 15189 ISO 17025

Our Services (4)


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Biospecimen Management and Storage

Price on request

Eurofins Central Laboratory deploys a full service in-house sample repository in all 4 testing locations and maintains procedures for sample handling logistics, long and short term storage, shipment to third-party laboratories, and destruction, as well as biorepository activities such as assessing specimen/package integrity... Show more »

Eurofins Central Laboratory deploys a full service in-house sample repository in all 4 testing locations and maintains procedures for sample handling logistics, long and short term storage, shipment to third-party laboratories, and destruction, as well as biorepository activities such as assessing specimen/package integrity upon receipt, corrective actions, handling customer complaints, and communication with clients.

Sample Management & Storage:

Dedicated sample management department.
Web-based online requisition system (EzRF- Eliminates query ratio by 80%)
Registration in LIMS (double entry).
Barcode labeling for sample tracking and automated results reporting into LIMS
Third-party lab shipment management
Sample storage at 2-8 °C, -20°C and -80°C and liquid nitrogen storage
Short and long term storage

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Central Lab Services

Price on request

Central Laboratory Services

Eurofins is a pure-play leading Central Laboratory with extensive experience in Phases I-IV clinical trials and works with top Pharma, biotech, and CROs to support drug development through laboratory testing, validation and assay development including Bioanalytical testing. We have the... Show more »

Central Laboratory Services

Eurofins is a pure-play leading Central Laboratory with extensive experience in Phases I-IV clinical trials and works with top Pharma, biotech, and CROs to support drug development through laboratory testing, validation and assay development including Bioanalytical testing. We have the informational infrastructure, project and investigator support, analytical capabilities and experience to develop and run assays in CAP/CLIA and GLP-like regulatory frameworks.

Specifically for Eurofins Central Laboratory, we provide the following services:

  • Global Clinical Safety and Specialized Testing Full package of routine and non-routine laboratory testing, including:
    • Routine Safety Testing (including Clinical Chemistry - Hematology - Urinalysis)
    • Allergy Testing
    • Biomarkers
    • Chemistry
    • Coagulation
    • Endocrinology
    • Flow Cytometry
    • Genomics
    • Haematology
    • Immunology
    • Immunohistochemistry
    • LC/MS/MS
    • Microbiology
    • Molecular Diagnostics
    • Pathology
    • Serology/Virology
    • Spectrophotometry
  • Biomarker Services
  • Logistics Support & Courier Management
  • Investigator Site Support
  • Sample Management & Storage
  • Project Management 
  • Data Management
  • Global Quality Assurance

 

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_,Methyleneadenosine 5diphosphate sodium salt all all assay development Assay Method validation Good Laboratory Practice Biology Drug Discovery Antibiotic Development Microbiology Pharmacology Toxicology Show 12 more tags Show less

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Biomarkers

Price on request

Fit-for-Purpose Biomarkers

Eurofins Central Laboratory offers exploratory and confirmatory biomarker analysis globally. For modern global clinical trials, utilizing disease-related biomarkers as surrogate endpoints is standard practice. Harmonization and standardization across all laboratory locations are critical for... Show more »

Fit-for-Purpose Biomarkers

Eurofins Central Laboratory offers exploratory and confirmatory biomarker analysis globally. For modern global clinical trials, utilizing disease-related biomarkers as surrogate endpoints is standard practice. Harmonization and standardization across all laboratory locations are critical for the validity of biomarker utilization. Commercial clinical analyzers and their associated testing kits find great utility in conducting such analyses, and verification of manufacturer specifications is often sufficient for the use in clinical [CAP/CLIA] laboratories.

Biomarker data that is used for decision making and for regulatory purposes, requires advanced method validation beyond CAP/CLIA verification. Eurofins Central Laboratory is uniquely positioned with our Biomarker Center of Excellence by uniting GLP and GCP in one synergetic approach. We are one-of-a-kind in offering advanced validation for biomarker assays on clinical analyzers. Our hybrid system allows us to combine best of both worlds when utilizing laboratory biomarkers to prove safety and efficacy, support go/no-go decisions, stratify patients, develop companion diagnostics and to support the submission of data sets to regulatory agencies worldwide.

Supported by an industry leading Scientific Team, biomarker assays are developed and fit-for-purpose validated to meet the specific requirements of your Clinical Trial Program. As our Biomarker Services are fully integrated into our Central Laboratory, we offer a seamless transition to a high volume production testing environment under one roof.

 

Validate versus Verify

The Eurofins Central Laboratory biomarker validation procedures are fit-for-purpose and may range from CLIA verification to advanced validation of biomarker assays. For method validation of biomarker assays, a distinction will be made between [1] biomarker data for exploratory purposes and [2] biomarker data in support of efficacy/safety decisions for regulatory purposes.

Category 1

Purpose: exploratory assessments of biomarker data (e.g. internal decision-making, understanding of pharmacodynamics [PD] or Mechanism of Action) and not drive label claims. This method validation exercise can be extended as deemed necessary, depending on the intended purpose of the data.

  • Category 1A: in vitro diagnostics (IVD); CE marked or FDA cleared assays; verification of manufacturer’s claim according to the CLSI/CLIA guidelines.
  • Category 1B: Research Use Only (RUO) assays, fit-for-purpose approach by validating at the level of sensitivity, precision, and accuracy on kit controls and precision on matrix samples of the disease state. Stability assessment can be considered on a case-by-case basis.

Category 2

Purpose: biomarker data used for pivotal safety and efficacy decisions in clinical development (intended for dosing/drug approval or labeling; data will be submitted to a regulatory agency).

For biomarkers assays intended for drug approval, the same questions need to be addressed as for an assay intended to measure drug concentration and therefore a similar validation approach as for pharmacokinetic (PK) assays should be performed. As such, the acceptance criteria as described in current FDA/EMA guidelines for bioanalytical method validation should be applied, where and when possible. Clinical biomarkers are not subject to GLP standards, but they should be considered and validated therefore as “fit-for-purpose” assays, meaning that the standard process for GLP validation should serve as the framework for the validation of biomarker assays as well.

At Eurofins Central Laboratory, our biomarker method development and method validation processes are in compliance with CLIA, FDA and EMA guidelines and published recommendations on biomarker assay validation.

Mark E. Arnold, Brian Booth, Lindsay King, Chad Ray.
Workshop report: Crystal City VI-Bioanalytical Method Validation for Biomarkers.
Published Online 11 august 2016. The AAPS Journal. DOI: 10.1208/s12248-016-9946-6.
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Clinical Sample Kits

Price on request

Kits Manufacturing and Distribution

With over 20 years of experience in Kit Packing and Distribution Services, Eurofins Central Laboratory is a turnkey provider that deploys lean, globally standardized processes, enabling high-quality GMP and FDA compliant specimen and transportation kits to be distributed... Show more »

Kits Manufacturing and Distribution

With over 20 years of experience in Kit Packing and Distribution Services, Eurofins Central Laboratory is a turnkey provider that deploys lean, globally standardized processes, enabling high-quality GMP and FDA compliant specimen and transportation kits to be distributed worldwide.

Eurofins Central Laboratory uses 3 wholly-owned and managed Kit Packing facilities in Louisville, KY, USA, Oosterhout, the Netherlands and Shanghai, China.

Global Logistics

Every year, Eurofins Central Laboratory produces and ships greater than 1 million specimen collection and transportation kits to investigator sites all over the world.

To facilitate ambient, cooled and dry ice transportation of this volume of human specimens back to the central laboratory, Eurofins utilizes preferred couriers which offer the best case scenario selected based on the country in question and service being performed. By using a limited number of couriers, we achieve greater operational efficiency and maximize volume discounts for the benefit of our customers.

Furthermore, by deploying just one universal, logistic operating procedure, regardless of the specific laboratory testing requirements, we are able to significantly lessen the burden placed on investigators and research nurses.

Sample Tracking and Tracing

Eurofins Central Laboratory has a full global logistics system in place to transport samples. This system is supported by a customized track-and-trace system, ensuring quality, monitoring the conditions of the samples, and allowing direct tracing of shipments of clinical lab supplies from our Kit Packing facilities to investigator sites, sample shipments from sites to Eurofins Central Laboratory testing facilities as well as from sites to third-party laboratories [when booked on a Eurofins Central Laboratory Account number].

Eurofins Central Laboratory's Kits & Logistics

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  • Positive review for Bioanalytical Assays:

    December 2017

    "Bruce from Eurofins was very helpful in coordinating the study I needed and Marcel in the Netherlands conducted the work in a relatively speedy manner and provided high quality data (clinical cancer biomarker assay run on pre-clinical samples). I would work with them again."

Eurofins Central Laboratory has not received any endorsements.