Hyderabad-based Excelra Knowledge Solutions has extended its GOBIOM (Global Online Biomarker Database) license to the Biomarker Qualification Group of the USFDA.
Excelra collaborated with the USFDA in the year 2008 in developing the safety biomarker content in GOBIOM and since then USFDA has been utilizing the database in its biomarker qualification process.
GOBIOM database will assist USFDA in better understanding the impact of clinical trial design and selection of outcomes measures, provide information about potential, common or intersecting areas of both drug and device developmental programs to USFDA reviewers, answer fundamental questions regarding biomarkers during regulatory review & decision making and help in identifying new biomarker candidates for further consideration.
GOBIOM (Global Online Biomarker Database) is Excelra’s proprietary repository of pre-clinical, clinical and exploratory biomarkers. It has a collection of over 80,000 Biomarkers covering 18 therapeutic areas and more than 1,800 therapeutic indications that have been manually extracted from Scientific and Regulatory literatures. fii-news.com
