The Nordic Bioscience Laboratory offers a complete range of central laboratory services assessing biochemical markers. In addition to regular safety testing of human samples from clinical trials, we are the exclusive provider of the unique Nordic Bioscience assays.
All aspects of our laboratory services are conducted in compliance with international standards for Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP). Our operations are accredited by the College of American Pathologists (CAP) and are ISO9001 certified. Our laboratory information management system supports compliance to FDA 21 CFR Part 11.
Our laboratory has provided central and specialized laboratory services to the pharmaceutical and biotech industries for more than 15 years. Our operations are highly scalable and our dedicated staff currently report more than 270,000 data points every year. We report >90% of all safety-related parameters in 3 days or less. Since 2010, we have provided central laboratory services to five multinational clinical trials conducted in North and South America, Asia and Europe with a total of over 10,000 subjects enrolled.
Our specialized clinical biomarker laboratory provides customized solutions. We provide a biomarker expert and an experienced project manager with a skilled protect team that closely interacts with the customer throughout the project life cycle, from project design to execution and customized biomarker data delivery, to clinical biomarker data interpretation.
Nordic Bioscience’s IVD Manufacturing Department produces high-quality biomarkers under GMP-regulation (ISO13485 certified) with traceability and reproducibility. In addition, we offer advanced validation and support to customers that request validation according to FDA and EMA guidelines.
Please note, that due to the COVID-19 situation, CAP has decided to postpone our upcoming inspection beyond our anniversary date. The accreditation is a continual process and our laboratory will remain accredited until otherwise notified. Please see below attached statement from The College of American Pathologist (CAP).