The clinical diagnostic testing services support and accelerate the market entry of new drugs, vaccines and antivirals, and assist in pre- and post marketing surveillance programs. Services are customized to specific needs, enabling maximum flexibility from day-to-day analysis to high throughput bulk analysis.
The clinical trial operations department is the latest addition to Viroclinics-DDL Diagnostic Laboratory. It provides better logistics support for the pharmaceutical, biotechnology, and medical device industries and gives Viroclinics-DDL the opportunity to monitor the quality from the moment the sample is taken to the final test results.
Preclinical services include testing of efficacy, safety, PK and (immune) toxicology of drugs, antibodies, vaccines and antivirals targeting viral infectious diseases. The BSL-2 and BSL-3 facilities enable complicated experiments with highly pathogenic viruses. The qualified biotech staff and use of state of the art BSL2 and BSL3 animal facilities are key to a successful outcome of studies.
Assay innovation and the introduction of new tools keep analysis up to date with the increasingly demanding criteria for developing new therapeutic and prophylactic candidates up to market registration. Customized assay and protocol development is followed by standardization and validation procedures to allow for routine application in a clinical trial setting.
Viroclinics-DDL Diagnostic Laboratory has adopted a high quality standard in all operations, testing procedures and reporting. The quality management system is based on NEN-EN-ISO 15189, GLP and expanded with elements of GCP, to comply with regulatory requirements and facilitate regulatory submissions.
Viroclinics-DDL Diagnostic Laboratory participates in global surveillance programs to monitor and characterize novel virus threats to human and animal health (EMPERIE; EU FP-7). Additional research programs focus on genomics, discovery of biomarkers, correlates of protection and viral reference strain development.
LEARN MORE ABOUT OUR SISTER COMPANY DDL DIAGNOSTIC LABORATORY
DDL Diagnostic Laboratory (DDL) is a state-of-the-art laboratory specialized in (molecular) diagnostic testing and diagnostic assay development. DDL performs advanced (molecular) diagnostic testing on behalf of pharmaceutical companies and clinical laboratories, within the complex framework of preclinical studies and Phase II-IV clinical trials. DDL also designs, develops, and validates novel diagnostic assays, which can be tailor-made for specific diagnostic purposes. Read more on DDL’s website here.
HIGH QUALITY EXPERT VIROLOGY CONTRACT RESEARCH LABORATORY
Viroclinics-DDL Diagnostic Laboratory operates at a global level, being the preferred virology testing laboratory for several of the top-10 Biopharmaceutical companies. As a virology contract research organization, we serve the biopharmaceutical community with our preclinical, clinical diagnostic, assay development and clinical trial logistics services. Our extensive experience with clinical and preclinical studies for viruses, including our specialty in respiratory viruses, puts us at the forefront for supporting the development of vaccines, antibodies and antiviral compounds targeting viral infectious diseases. Our staff consists of over 280 well-trained, dedicated scientists and technical experts, and our projects are supported by an extensive network of key opinion leaders as consultants. Through an intense collaboration with the Erasmus MC Viroscience Lab, we offer the combined benefits of scientific knowledge and technical ability maintained at both laboratories. This enables Viroclinics-DDL to support customers with the best virological knowledge available. Our uniquely consultative approach to business means we nurture deep client relationships in order to fully understand their needs and provide optimally customised research programs and project solutions.
BSL 2 AND BSL 3 FACILITIES AND HIGH QUALITY
Viroclinics-DDL Diagnostic Laboratory is a cutting edge lab service organisation with state of the art facilities including laboratory BSL 2 and BSL 3 facilities and a samples processing facility in New Jersey USA. Viroclinics has adopted a high quality standard in all operations, testing procedures and reporting. The quality management system is based on NEN-EN-ISO 15189, GLP and expanded with elements of GCP, to comply with regulatory requirements and facilitate regulatory submissions.
After the acquisition of Viroclinics-DDL by the group Cerba Healthcare, we are delighted to announce that Cerba Research, the group’s global clinical trial central and speciality laboratory services division, has now merged with Viroclinics-DDL, a fast-growing global specialist virology and immunology contract research organisation (CRO).
Viroclinics Xellerate provides better logistics support for the pharmaceutical, biotechnology, and medical device industries and gives us the opportunity to monitor the quality from the moment the sample is taken to the final test results. All personnel who are involved in the clinical trial are trained and all processes, temperature monitoring and assays are performed according to the ISO 15189 accredited quality system.
Logistic activities include preparation of virology sampling kits, on-site sampling handling instruction, courier transport, sample tracking and tracing (e.g. guaranteeing temperature controlled supply chain and online-sample timelines) , and management of sample processing labs. Viroclinics Xellerate support a smooth logistical flow of samples from all over the globe, and works together with a network of 36 processing laboratories in USA, Turkey, Mexico , Panama, Costa Rica, Argentina, Brazil , Peru ,Japan, South Korea, Singapore , China, Poland, Australia, India, South-Africa , Israel, Russia , Ukraine, Serbia, Colombia, UK, Germany, Spain, Saudi Arabia and Moldova.
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• Detection of nonhemagglutinating influenza a(h3) viruses by enzyme-linked immunosorbent assay in quantitative influenza virus culture.
• Performance evaluation of the new Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 test version 2.0 for quantification of human immunodeficiency virus type 1 RNA.
• Comparison of the Abbott Realtime HIV-1 and HCV viral load assays with commercial competitor assays.
• Evaluation of the analytical performance of the new Abbott RealTime RT-PCRs for the quantitative detection of HCV and HIV-1 RNA.
• Multicenter evaluation of the new Abbott RealTime assays for quantitative detection of human immunodeficiency virus type 1 and hepatitis C virus RNA.
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