The Hyderabad-based GVK Bio, one of the leading Contract Research Organisations in the country (CRO), recently extended its clinical biomarker database (GOBIOM) license to the biomarker qualification group of the US Food and Drug Administration (US FDA).
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. It 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. According to the company, 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 US FDA in its biomarker qualification process.
“The collaboration with the US FDA 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”, said, Sreeni Devidas, vice president, Sales and Marketing, Informatics, GVK Bioscience
It is learnt that GVK Bio, a leading discovery research and development organization that provides a broad spectrum of services, stand-alone and integrated, across the R&D value chain, has extended the license for a period of one year and the license is perpetual in nature. However, the company has declines to reveal the financial terms of the same.