Eurofins Global Central Laboratory - Netherlands

Eurofins Central Laboratory BV
Bergschot 71
4817 PA
Breda
THE NETHERLANDS

Phone: +31 76 572 72 72
Fax: +31 76 573 77 78

clinicaltrials@eurofins.com

centrallab.eurofins.com

Eurofins Global Central Laboratory is one of the industries leading global central laboratories worldwide, supporting clinical trials in more than 50 countries across six continents. At Eurofins, laboratory science is our sole focus and we are fully dedicated to providing standardized, high quality global central laboratory services to support all phases of clinical trials. With over 20 years of experience and scientific accomplishment, our laboratory testing portfolio has become one of the widest available in the pharmaceutical industry and offers the synergy of integrating all laboratory services in clinical trials.

Eurofins Global Central Laboratory supports its customers with six wholly owned and harmonized facilities in the United States, the Netherlands, France, India, Singapore and China. Our laboratories use the same global standard operating procedures, and the same global reference ranges through uniform instruments, reagents, and analytical methods. All of our owned laboratories are connected to one global LIMS.

In some cases, we utilize strategic partner laboratories to meet the specific cost related, logistical or local needs of a given study. If required, we can extend our global footprint through our standardized partner network with local central laboratories in Japan, South Africa and Argentina.

These harmonized laboratories use the same global standard operating procedures, reference ranges and state-of-the-art IT infrastructure to assure standardized data for submission to health authorities worldwide.

Eurofins is one of only three companies worldwide with this global capability.

Eurofins Global Central Laboratory provides a full range of services to support every stage of drug development, from preclinical, through clinical phases, through post marketing. Our range of expertise comprises all therapeutic areas, including oncology, cardiovascular, infectious disease, transplantation, and others.

Laboratory testing portfolio

Global Clinical Safety and Specialized Testing full package of routine and non-routine laboratory testing, including:

• clinical chemistry
• hematology
• immunochemistry
• urinalysis
• coagulation testing
• flow cytometry
• biomarkers
• hormones
• cell markers
• cytokine profiling
• infectious disease serology
• routine genomic testing
• DNA/RNA isolation and long term storage

Biomarker Services

• Biomarker-mediated Drug Development
• PD - target engagement biomarkers, proof-of-mechanism and proof-of-concept biomarkers
• biomarkers in clinical trials (exploratory and clinical end-point)
• fit-for-purpose validation and analysis of commercially available biomarker assays o biomarker analysis in non-conventional biological matrices
• broad range of applied technologies: ELISA, MSD, Luminex, Flow cytometry and LC-MS/MS

Bioanalytical Services

• pre-clinical and clinical bioanalysis
• method development and transfer
• method validation
• TK
• PK/PD
• bio-equivalence studies
• daily therapeutic drug monitoring in clinical trials
• Dried blood spots

Biopharmaceutical Services

• PK analysis of biopharmaceuticals, including MoAb drugs, oligonucleotide drugs, biologics, biosimilars
• immunogenicity testing of biopharmaceuticals and biosimilars
• vaccine-mediated immunogenicity (non-infectious disease)
• screening and confirmation assays
• functional bioassays (cell-based assays)
• scientific consultancy
• Global Infectious Disease Services
• central laboratory microbiology to support clinical trials
• clinical virology services
• non-clinical specialty tests for compound profiling, cidality, resistance development, drug interactions
• international antimicrobial surveillance programs
• extensive repository of clinically relevant bacteria
• scientific consultancy

Clinical trial supporting services

• Logistics Support and Courier Management
• global footprint to ensure specimen integrity and optimal turn around time
• one logistic operating procedure for all laboratory testing applications
• dedicated specimen kit assembly facilities
• study and visit specific specimen collection kits
• intuitive tailor-made laboratory testing request form
• site instructions for specimen collection, preparation and packaging for shipping
• specimen shipping procedure, materials and courier contact information
• track and trace
• import and export licenses consultancy for Asia-Pacific

Investigator Site Support

• study specific investigator laboratory manual
• study and visit specific specimen collection kits
• summary flow charts for experienced users
• visit specific test schedules
• multilingual regional helpdesk on three continents
• daily results reporting by fax, 3-part NCR reports by mail
• access to real-time global results database via secured Eurofins Medinet Data Portal (EMDP)

Sample Management and Storage

• dedicated sample management department
• registration in LIMS (double entry)
• barcode labelling for sample tracking and automated results reporting into LIMS
• outbound shipments o sample storage at 2-8 °C, -20°C and -80°C
• long term storage upon sponsor request

Project Management

• global study set-up
• study specific materials including investigator laboratory manual, specimen kits, shipping materials
• training investigator sites
• single point of contact for monitor
• monitoring timelines
  issue management, query solving o budget management

Data Management

• study priming in global LIMS
• data cleaning
• electronic data transfer in sponsor defined format
• CDISC compliant
• daily results reporting using EMDP, fax and or print reports

IT Systems and EMDP

• flexible global IT infra-structure to accommodate clinical trials of any nature, size, foot print or complexity
• global LIMS
• real-time global results database via secured Eurofins Medinet Data Portal (EMDP)
• study enrolment progress reports
• flagging alerts for out-of-range test results
• trend analysis tools
• study specific, customized analysis tools upon request

Global Quality Assurance

• annual process audits cross inspecting all Eurofins Global Central Laboratory facilities worldwide
• data integrity audits
• study specific audits
• global document control
• building and maintaining global standardized operating procedures
• issue management coordination, analysis and improvement programs
• key performance indicators

 

Eurofins Global Central Laboratory uses several well-recognized international quality standards and regulatory guidelines to control its activities.

Our Global Quality System (EMQS) is founded on the following quality standards: CAP, CLIA, ISO 15189:2007, ISO/IEC 17025:2005, OECD GLP guidelines and GCP guidelines where applicable.