Under the terms of the collaboration, Thermo Fisher and Megaware will market a new comprehensive end-to-end software solution which provides bioequivalence functionality on a single platform to help speed up and manage clinical trials. Rapid market growth in generic drug production is driving the requirement for fast efficient bioequivalence studies to meet FDA ANDA guidelines (Abbreviated New Drug Applications). A unified software solution will aggregate disparate software systems for organizations that demand tools to speed service and management of this critical and regulated IPO.
“The market for bioequivalence studies in India and the Far East is growing rapidly, and the Thermo Scientific Watson LIMS is seen as the de facto standard for bioanalysis/equivalence. Thermo Fisher’s unparalleled strength in this field complements Megaware’s in-depth experience with the CRO industry in the market,” said Dave Champagne, vice president and general manager of informatics for Thermo Fisher. “Our collaboration with Megaware will lead to the first total solution for this market, eliminating time and administrative burden from the bioequivalence challenge.”
The two companies will work together closely to target the market for bioanalysis/equivalence studies, initially in India and thereafter across the Far East and other markets. The market in India for clinical trials is growing rapidly, because the average cost of trials is significantly lower than in the United States and Europe. The consultancy firm McKinsey estimates that US and European pharmaceutical companies will spend US $1.5 billion per year on clinical trials in India by 2010.
Thermo Fisher and Megaware will jointly sell, market and support the new solution in the field. Thermo Fisher will bring its bioanalytical expertise to the partnership and Megaware, with headquarters in Westborough, MA and Mumbai, India, will deliver the end-to-end technological focus combined with on-the-ground market knowledge. The new solution will offer higher throughput, greater levels of compliance and standardization of bioequivalence processes.
“We have an established customer base in contract research and pharmaceutical companies in India, who are encouraged by the development of robust enterprise automation solution to enable them to gain FDA approval quicker, adds Ajit Nagral, President of Megaware Inc. “We believe that Thermo Fisher, and Megaware, together deliver the best-in-breed solution for this market.”