Clinical and drug-development processes have experienced a lot of change over the past 10 years.  This has been influenced mostly by rapidly evolving technological trends, expansion of clinical trials into global markets, such as Russia, India and China & a push for a universal paperless system, which most believe, will help improve patient treatment and care.

Between 30 to 50% of time is spent on clinical studies in R&D by pharmaceutical companies and  30% of this time goes in patient recruitment. Companies try to save time from this period as the patent protection for a product is limited to 20 years and any time saved here can help them reap additional revenues.  Finding the adequate study population in time, particularly in smaller geographies with small population densities, particularly in the West, causes a delay in 80% of clinical trials.

This has forced the pharmaceutical industry to utilize ‘outsourcing’ strategies to focus more on the core skills. In the late 90’s, the CRO industry evolved this way.

The outsourcing to Asia Pacific region is on the rise. Asia accounts for more than 60% of the world’s population. 1/3rd of the world’s population live in China and India providing a vast patient base and the advantage of benefiting from relatively expensive treatment.

The cost benefits of conducting a clinical trial in India are well proven by the 50% savings in conducting phase I, and nearly 60% in conducting phase II & III trials. This is supported by the government initiatives by signing the TRIPs agreement and setting up a regulation to protect intellectual property rights; by providing fiscal incentives to research-based companies and by allowing the same phase studies (as the country of origin) to be initiated in India.

India occupies a very small pie of the global market share in the clinical trials industry but it is estimated to conduct nearly 5% of global clinical trials by 2012.  The global CRO industry is valued $18 billion in 2008 and the market is expected to grow at an annual rate of 14% between 2011 and 2015. The main five focus areas are: oncology, diabetology, cardiology, neurology/psychiatry & nutrition. Lotus Labs has considerable experience with the conduct of clinical trials and its FDA submission studies have been audited by the regulatory body.