Audits & Accreditations
The GVK BIO in-house Clinical Laboratory received ANVISA certification.
The laboratory is already NABL and ISO 15189 certified.
The 120 bed Ahmedabad unit of the Clinical Pharmacology division, set up in March 2010 was successfully audited and certified by the ANVISA authorities. Earlier this year, it cleared the Ministry of Health, Turkey audit.
The Hyderabad center was also successfully re-audited by ANVISA .
Clinical Trial managed by GVK BIO declared as “Project of the Year”
A clinical trial (TA : infectious disease) managed and monitored by GVK BIO, focused on Visceral Leishmaniasis Combination Therapy, was selected as Project of the Year 2010 by a Swiss-based NGO. GVK BIO’s involvement in the trial was acclaimed by the sponsor in a partners meeting attended by 150 researchers from Government of India, product development partners, academia, pharma, biotech, NGOs representatives and international health experts around the world.
GOBIOM reaches out to Academia
Dr. Atul J. Butte and his group from Stanford University, cited the utility of our Biomarker database (GOBIOM) for their work on “Method for Monitoring Allograft rejection” ( WO 2010/093869 A1).The same group have also cited the use of GOBIOM in PLoS Journal article. GOBIOM (GVK BIO Online Biomarker Database) is an online scientific database product of GVK BIO.
As a part of their research, they compared their predicted protein sets with known diagnostic protein biomarkers in the clinical and preclinical studies in GOBIOM. GOBIOM contains 12,000 known biomarkers for 493 therapeutic indications curated from 31,000 unique references. For 22 out of 41 diseases, known diagnostic protein biomarkers were statistically significantly enriched in our predicted protein sets.
The result of the study demonstrated that integrating gene expression microarray measurements from disease samples with publicly-available data sets can be a powerful, fast, and cost-effective strategy for the discovery of new diagnostic serum protein biomarkers.
Clinical Trial Databases from GVK Biosciences and Quantitative Solutions
GVK BIO in collaboration with QS offers Clinical Outcomes Databases for a number of therapeutic areas/indications along with customization services to suit specific modeling needs. The databases are widely used by several modeling and simulation (M&S) groups across the globe in Model Based Meta Analysis (MBMA) programs.
The database has 10 indications completed as products with more in the offing.
- Rheumatoid Arthritis
- Neuropathic Pain
- Lower Back Pain
- Osteoarthritis Pain
GVK Biosciences co-hosts Symposium with GSK
GVK Biosciences was a key sponsor of the GlaxoSmithKline hosted 3 day Symposium on “Practical Applications of Modern Tools in Organic Synthesis and Purification” held from 21st-25th November at IICT Hyderabad.
More than 500 participants from the industry and academia attended the event organized with an aim to emphasize the practical applications of modern tools in organic synthesis and purification. The workshops organized helped increase awareness of technologies and techniques that could increase efficiencies in synthesis and purification for both scientists and managers.
Eminent speakers included Prof. Mark Bradley, University of Edinburgh, UK and Prof. Oliver Kappe, University of Graz, Austria.