GVK Biosciences Extends License of its Biomarker Database to the USFDA
April 25, 2011
April 25, 2011 — GVK Biosciences (GVK BIO) announced that it has extended its Clinical Biomarker Database (GOBIOM) license to the Biomarker Qualification Group of the US Food and Drug Administration (USFDA). The GOBIOM database which has the latest and updated information on all the biomarkers reported in various clinical and preclinical studies will be of enormous use to USFDA in its Biomarker Qualification Process.
The GOBIOM database is a comprehensive collection of all the clinically evaluated, exploratory and preclinical biomarkers associated with different therapeutic areas reported in global clinical trials, clinical and preclinical studies. GOBIOM contains information on 12,000 biomarkers comprising of Biochemical, Genomic, Imaging, Metabolite, Cellular and Physiological markers with multiple data points covering experimental, analytical, clinical and statistical data with their qualifications under different medical interventions.
Sreeni Devidas, Vice President, Sales & Marketing, Informatics said “The collaboration with the USFDA helped GVK BIO in developing the safety biomarker content in GOBIOM. The interconnectivity between the organ toxicities to the drug, dose and population was developed with equal emphasis on its preclinical qualification. Biomarker analysis tools were integrated into the database such that the user can make comparative analysis between the biomarkers of their interest.”
About GVK Biosciences
GVK Biosciences (GVK BIO) is Asia’s leading Discovery Research and Development organization. GVK BIO provides a broad spectrum of services, stand-alone and integrated, across the R&D value chain. Our discovery services consist of Chemistry, Biology and Informatics; the development services include Clinical Research, Clinical Pharmacology and Process R&D. GVK BIO’s diverse portfolio of more than 150 customers includes some of the world’s largest pharmaceutical, biotechnology, agro, life-sciences companies and leading academic institutions.