Eurofins Clinical Trial Solutions

Integrated Lab Performance and BioPharma Solutions From the Organization You Trust

From compound discovery and clinical research through manufacture and release of commercial product and post-approval/marketing, Eurofins Clinical Trial Solutions provides seamless, end-to-end solutions to help clients progress through the drug development cycle through a single, experienced provider. Our integrated solutions deliver the most comprehensive range of state-of-the-art analytical technologies with an expansive geographic reach in order to support our clients’ specialized testing needs and stringent quality and safety requirements around the world.

Eurofins Clinical Trial Solutions Span the Complete Product Development Cycle

Bioanalytical Services

Biologics Done Right.

Eurofins Pharma Bioanalytical Services is a biologics-focused, global leader in bioanalytical solutions providing over 20 years of industry-leading scientific expertise. We specialize in comprehensive PK/TK, ADA, NAb, biomarker assays and sample analysis for the world’s largest pharmaceutical and biopharmaceutical companies. Our mission is to extend our clients capabilities of improving global health by combining scientific knowledge, capacity, regulatory expertise and flexibility to provide the trusted, relevant information required for the drug approval process. At the forefront of employing novel approaches to overcome the most complex assay challenges and industry-leadership in developing and performing immunoassays on human and animal specimens, we offer trusted bioanalytical solutions to support studies ranging from preclinical non-GLP to IND-enabling Toxicity studies to multi-national Phase III clinical trials. We can take your biologic drug from research through development to FDA regulatory submission.

• Over 15 years of industry-leading global Scientific Expertise supporting the widest breadth of biologics’ clinical trials with PK/TK, ADA, NAb and biomarker assays and sample analyses.
• Versatile performance to adapt to a client’s specific needs. Clinical or preclinical, regulated or non-regulated, assay development, qualification or validation; we custom design our support to match the client’s program.
• State-of-the-art laboratory facility in St. Louis, USA providing Global Reach and Capacity to address clients’ needs while simultaneously offering regionally-based solutions.

Central Laboratory

Results That Matter.

Eurofins Central Laboratory has 15 years of extensive experience in Phases 1-4 clinical trials, and works with top Pharma, biotech, and CROs to support drug development through clinical laboratory testing, assay development and assay validation.

At Eurofins Central Laboratory, we are the BOLD solution to the BioPharma industry!

With our four standardized, wholly-owned global locations [US, Netherlands, Singapore, China] we provide CAP/CLIA certified analytical services in both a GCP & GLP environment. This allows us to combine Safety/Efficacy analysis with Biomarker Services embedded within one laboratory. Introducing cost efficiencies into your study budget, 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 makes us BOLD? Innovation. Whether that is our specimen visibility tool, EzRF (web based requisition), our home based, 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.

Specialty Clinical Laboratory

Get Results Faster, When it Matters Most.

With more than 40 years of experience, Eurofins Viracor BioPharma is a specialty testing laboratory that helps advance their clients' Phase 1-4 clinical trials through trusted partnership, excellence in science and exceptional service. Eurofins Viracor BioPharma offers your development program an extensive menu of over 3,000 validated tests in the areas of molecular and infectious disease, allergy/hypersensitivity and immune response monitoring.

We can develop and customize assays to meet your trial’s needs through our specialized testing and expertise in complex assay design/transfer, optimization and validation. To meet the specific needs of your protocol, our Research and Development team serves as an extension of your laboratory, providing the following approaches to assay validation:

Custom de-novo or Fit for Purpose (e.g. No testing previously performed by client) Feasibility, development, optimization, pre-validation and validation

Partially Validated Transfer (e.g. Some testing previously performed by client) Familiarization, development, optimization, pre-validation and validation

Fully Validated Transfer (e.g. SOP and validation report provided by client) Pre-validation and validation

Eurofins Viracor BioPharma accepts a broad range of specimen types available on over 15 different platforms, widening our capabilities and enabling us to customize our testing to your trial’s exact needs. Eurofins Viracor BioPharma is a CAP accredited/CLIA certified laboratory and we adhere to GCP guidelines.

Eurofins Viracor BioPharma's high-throughput clinical laboratory can support your clinical trials with the capacity to process large sample volumes quickly, support studies with short set up timelines and provide rapid testing turnaround times. Our project managers and scientists act as part of your team – going above and beyond to get you the results you need when they are required.

We’re driven to partner with you to solve difficult scientific problems, complementing your strategies with assay development/validation services and the expertise and agility to manage trials of any size with exceptional turnaround time – accelerating your vaccine, compound, immune therapy or biological from bench to market.

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Genomics

Fast-track Your Path.

Eurofins Genomics provides Oligonucleotides, Sanger Sequencing, Gene Synthesis, and Next Generation Sequencing with rapid turnaround times and industry leading quality to fast-track your path to the next blockbuster drug.

• Low-error rate, high-speed oligos highly suitable for BioPharma, due to its exclusive new synthesis technology. In addition, express Oligos are delivered the next day for no additional charge. EXTREmer long oligos are a premium product that performs well in tough applications such as NGS and synthetic biology. Modified nucleotides at different lengths and scales are also available.
• Rapid turnaround time for Sanger Sequencing and custom Primer Synthesis. Sequencing results are provided overnight, nationwide, due to unique logistical advantages. Also, the typical read length exceeds 1,000 and outperformed all other comparable suppliers in a head-to-head comparison. The adjacent Sanger sequencing and oligonucleotide synthesis labs ensure that you get your sequence data quickly – custom primers are synthesized and immediately delivered in the sequencing lab to be used in the sequencing reaction. Very few suppliers offer the same synergies between product and service groups within the same lab.
• Rapid turnover for the synthesis of Genes or GeneStrands: Eurofins Genomics can optimize the gene (using the proprietary software GENEius) for optimal protein expression, synthesize the required oligonucleotide fragments, and assemble the gene or GeneStrand, ready for your use in a short time.
• Four interdependent, global laboratories which provide redundancy and reliability for custom oligonucleotide synthesis, Sanger Sequencing, Genes, and Next Generation Sequencing.
• Eurofins Genomics is the best genomics partner to increase the pace of your research.

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Anatomical Pathology

Specialized Medical Pathology.

The deployment of pathology testing has become increasingly important in oncology trials. Pathology testing is facing similar challenges as central laboratory testing; large sample numbers distributed over many locations, a need for expert global logistics support to maintain specimen integrity, quick turnaround time of results and the necessity for globally combinable data.

With a keen eye on the specifics of a clinical trial, Eurofins Biomnis offers anatomic, clinical and molecular pathology services to assess traditional clinical-pathological factors as well as the molecular biological features of a given tumor to support safety, vaccine and oncology trials.

Eurofins Biomnis focuses mainly on specialised pathology testing, which requires highly skilled expertise, and which cannot be performed in routine private or hospital-based laboratories. Eurofins Biomnis specialises in all areas of pathology and testing is performed using the most recent and cutting-edge techniques, which necessitate complex calibrations and validations, highly qualified experts and sophisticated equipment.

• Surgical pathology
• Tumor confirmation and classification
• Pathology reads for efficacy
• Slide preparation and preservation
• Histology
• Cytology
• Molecular pathology
• FISH
• IHC
• Flow cytometry
• Customized methodologies using sponsor-defined processes
• Genetic pathology
• PCR-based methods
• SNP arrays/DNA chips
• Next generation sequencing

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Early Clinical Development

Early Drug Development Experts.

Eurofins Optimed is the clinical competence center of the group, providing integrated solutions for the global management of international clinical trials, to the pharma, biotech, and medical device industries.

Focused on early clinical development, our experience of more than 1,000 trials conducted since our creation establishes us as a reliable partner. We are able to provide you with GCP services in any therapeutic field thanks to our experienced team of experts and our large network of Key Opinion Leaders.

As every clinical project is specific, we offer tailor-made solutions among the following activities:

• Study document development: protocol, ICF, e-CRF, diaries, IMPD
• Regulatory support and submissions in Europe and in the USA
• Clinical Investigations: in our Clinical Pharmacology Unit (France – 60 beds) or through our network of Investigators within Europe and the USA
• Support services: feasibility studies (site identification and qualification), project management, site coordination, monitoring
• Data collection and analysis: data management, statistics, e-CRF, medical writing, ePro

Our unified e-clinical platform spans clinical operations and clinical data management. It provides a multi-tenant cloud and mobile-based workspace for all drug development activity. This system provides users with complete clinical trial transparency, ensures data consolidation with a single database and offers advanced reporting including integrated dashboards, KPIs, standard reports and ad hoc reports.

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