We have been providing laboratory services to the pharmaceutical and biotech industries for over 15 years and our laboratory services extend worldwide from the United States to Asia. Since 2010, Nordic Bioscience Laboratory (NBL) has been committed to the highest level of quality with a history of reporting accurate and high-quality results and is the only laboratory offering CAP-accredited services in Scandinavia.
In that time, we have provided central laboratory services for five multinational clinical trials in North and South America, Asia and Europe, involving a total of over 10,000 subjects. Our operations are highly scalable and our dedicated staff currently report over a test volume of 420,000 sample results per year. We report > 90% of all safety-related parameters in 3 days or less.
Our CAP lab provides customized solutions that match the research scale of clinical trials and includes various subtypes of laboratories and platforms that provide highly accurate data for clinical decision-making.
We provide a biomarker expert and an experienced project manager with a skilled team that works closely with the client throughout the project lifecycle: from project planning, lab validation report, biomarker data execution and delivery, to clinical biomarker data interpretation.
In addition to regular safety testing of human blood samples from clinical trials, we are the exclusive provider of the unique Nordic Bioscience biomarker assays.
An example of a customized solution is that we are measuring Siemens Enhanced Liver Fibrosis (ELF) Tests, including both ELF scores and composite scores. In case you require further assessment, we provide PRO-C3 and other standard liver function tests performed together with The ELF Blood Test, such as Aminotransferase (ALT) and Aspartate Aminotransferase (AST) tests.
All aspects of our laboratory services are performed in accordance with international Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) standards. Our facility is accredited by the College of American Pathologists (CAP) and is ISO9001 certified. We have been CAP-accredited since 2010, and gained our ISO9001 certificate in 1996 and ISO 13485 in 2016. Our laboratory information management system supports compliance with FDA 21 CFR Part 11. All laboratory activities are closely monitored by an independent quality assurance team, and all study-related deviations are reported back to our customers for transparency.
Nordic Bioscience's IVD Manufacturing Division produces high-quality biomarkers under GMP regulations (ISO13485 certified) with traceability and strong reproducibility. In addition, we provide advanced biomarker validation and support for customers requiring validation according to FDA and EMA guidelines and platforms that enable highly accurate data.
Please don't hesitate to contact us if you have any questions or other inquiries.