Databases for Clinical Trials

AP, INDIA: GVK Biosciences (GVK BIO), Asia's integrated research services provider and Quantitative Solutions (QS), a modeling and simulation (M&S) consultancy to the pharmaceutical and biotech industry, have announced a strategic partnership to develop and market clinical trial outcome databases. The databases capture summary level data for the clinical safety and efficacy outcomes from publicly available data sources.

As per the terms of the agreement, GVK BIO will distribute globally existing QS Databases in five indications including Rheumatoid Arthritis & Psoriasis, Chronic HCV, Neuropathic Pain, Osteoporosis (postmenopausal) and Major Depression immediately. GVK BIO and QS plan to jointly develop and market additional databases in Dyslipidemia, Schizophrenia, Alzheimer's, and other indications shortly.

"Meta-analyses involving publicly available clinical data provide valuable insights to drug development and marketing programs. We have seen significant increase in demand for this type of analysis and are excited about the opportunity to work with GVK BIO to expand product offerings in Clinical Outcomes Databases. I believe that our customers will benefit greatly from the integrated products and services this partnership provides" said Dr. Jaap Mandema, Founder & CEO, QS.

Dr. Sreeni Devidas, VP Business Development, GVK BIO commented "The alliance with QS is a major step to create infrastructure that supports the now mandated model of quantitative drug development. Pharmacokinetic/pharmacodynamic M&S are well-recognized powerful tools and this collaboration enables us to develop platforms that will help maximize their utility and value in drug development".

The Clinical Trial Outcome Databases are designed to assist drug development teams conduct comparative efficacy and safety analysis, link/scale biomarkers to clinical outcomes, predict/improve trial outcome, and develop product differentiation strategies. The databases will be supported by customization and M&S consulting services provided by GVK BIO and QS, respectively, to ensure maximum flexibility and benefits to the clients, added the press release.