Thermo Fisher and Megaware say they will market 'comprehensive end-to-end software' which provides bioequivalence functionality on a single platform to help speed up and manage clinical trials
Thermo Fisher Scientific announces a new strategic partnership with Megaware, a life science technology organisation, to deliver a new bioanalysis/equivalence solution and joint support services for pharmaceutical, biotech and contract research organisations (CROs).
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 will aggregate disparate software systems for organisations that demand tools to speed service and management of this critical and regulated IPO.
"The market for bioequivalence studies in India and Asia is growing rapidly, and the Thermo Scientific Watson Lims is seen as the de facto standard for bioanalysis/equivalence.
"Thermo Fisher' 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 Asia 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$1.5billion 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.
"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.
"We believe that Thermo Fisher, and Megaware, together deliver the best-in-breed for this market."
