Nordic Bioscience Laboratory offers a complete range of central laboratory services for the evaluation of biochemical markers. Ours is the only laboratory that offers CAP-accredited and services in Scandinavia. 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 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. Our laboratory information management system supports compliance with FDA 21 CFR Part 11.
Our laboratory has been providing centralized and specialized laboratory services to the pharmaceutical and biotech industries for over 15 years. Our operation is highly scalable and our dedicated staff currently reports over 270,000 data points per year. We report > 90% of all safety-related parameters in 3 days or less. Since 2010, 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 specialized clinical biomarker laboratory provides customized solutions and besides handheld ELISA measurements, our platforms include high precision equipment as well. We provide a biomarker expert and an experienced project manager with a skilled protection team that works closely with the client throughout the project lifecycle, from project planning, execution and delivery of customized biomarker data to interpretation of clinical biomarker data.
Nordic Bioscience's IVD Manufacturing Division produces high-quality biomarkers under GMP regulations (ISO13485 certified) with traceability and reproducibility. In addition, we offer advanced validation and support to customers who require validation according to FDA and EMA guidelines.