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US FDA Extends License of the GVK BIO Biomarker database

February 04th, 2013; 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.

Salient features of GOBIOM

  1. Controlled vocabulary throughout
  2. Web-enabled search application for quick and easy access
  3. Intuitive User Interface with comprehensive search features
  4. Instant generation of ‘biomarker report’
  5. Data export options in custom format to Excel, XML and PDF
  6. Provision of user-required data in their own formats
  7. Easy integration with client proprietary data
  8. On-demand service for any biomarker addition into the database
  9. Competitive intelligence analysis
  10. "Alert a Colleague" option to share the data with other users
  11. Biweekly update with auto alert function
  12. Custom alert by therapeutic area and biomarker name
  13. On-demand training sessions
  14. A dedicated server located in USA with backup server in India

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