Hyderabad, India: GVK Biosciences (GVK BIO) today announced that it is extending 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 recently updated information on all the biomarkers reported in various clinical and preclinical studies, will be beneficial to the USFDA in its Biomarker Qualification Process.
The GOBIOM database is a comprehensive compilation 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 20,000 biomarkers comprising of biochemical, genomic, imaging, metabolite, cellular and physiological markers, along with multiple data points comprising of 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 has helped GVK BIO in developing the safety biomarker content in GOBIOM. The interconnectivity between 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 in a manner that has facilitated the user to make a comparative analysis between the biomarkers of their interest. We look forward to continue working and collaborating with the FDA with a view to enhancing the utility of the product further."
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 comprise of Chemistry, Biology and Informatics; the development services include Clinical Research, Clinical Pharmacology and Process R&D. GVK BIO's diverse portfolio and prestigious clientele comprising of more than 200 customers includes some of the world's largest pharmaceutical, biotechnology, agro, life-sciences companies and leading academic institutions. Please visit us at www.gvkbio.com to know more.
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