HYDERABAD, India--(BUSINESS WIRE)--Excelra Knowledge Solutions today announced that it 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)
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.
Anandbir Brar, President, Excelra, said, “We are delighted to extend our collaboration with the USFDA after starting our collaboration back in 2008. With over 80,000 Biomarkers and more importantly the content and coverage of the database, we hope that the utility of the database to the NCTR and the Reviewers at the USFDA is further maximized.”
“We are delighted that the prestigious USFDA has renewed its license. We look forward to further collaborating with the agency and enhancing the value of the database. Inputs from the NCTR have been invaluable in enhancing the database since its inception in 2008,” said Dr. Sreeni Devidas, Vice President, Business Development at Excelra.
About Excelra:
Excelra Knowledge Solutions (formerly GVK Informatics) is a leading Informatics Solutions company that leverages its extensive scientific knowledge base, technology and relevant domain expertise to provide intelligent data and analytics solutions to customers globally. Its databases on SAR (GOSTAR), Biomarkers (GOBIOM) and Clinical Outcomes are widely used in the industry globally. Excelra’s expertise spans across Data Solutions, Data Indexing & Abstraction and Data Analytics. The company has over nine successful Drug Repurposing collaborations with leading Pharmaceutical companies and has developed a proprietary Drug Repurposing Platform and Computational Biology capabilities. Excelra has a team of over 650 scientists with rich experience in Chemistry, Biology and Clinical Sciences that are engaged in curation of databases spanning SAR, Biomarkers and Clinical Outcomes. These products are considered as Industry Standard and numerous publications have been made using the underlying content in the databases. The portfolio of customers includes some of the world’s largest Pharmaceutical, Biotechnology, Publishing, Agrochemical, Life Sciences and Academic institutions in the USA, EU, Japan and Asia Pacific.
