Clinical Trials are systematic studies conducted on healthy volunteers or patients, with the aim of examining a hypothesis. The most commonly performed clinical trials evaluate efficacy and safety of new drugs, medical devices, biologics, or other interventions on patients in strictly scientifically controlled settings, as required by regulatory authorities. These studies are often comparative and use standard drugs or at times, placeboes for comparison.

These trials are conducted in three phases, each being more complex than the earlier one. On successful completion of the studies, the data collected are submitted to the regulatory authorities for seeking permission to market the drug. In brief, clinical trials are an essential part of the new drug development program, following animal studies and prove that the drug has the efficacy and safety to be used in humans.

India has now become an attractive destination for clinical trials and pharmaceutical companies worldwide are setting up bases or outsourcing studies here. Additionally a number of Indian companies have developed indigenous molecules, which are awaiting trials in India.

Factors that drive the growth of the Indian Clinical Research market are as follows:

• Availability of a large, treatment native patient pool
• World class medical facilities
• Highly qualified and experienced investigators
• New IPR and Patent laws
• Strict adherence to ethical principles
• English being the language of communication
• Cost competitiveness