Why India?   Clinical Research Industry      Europe      Asia      Latin America      United States   Clinical Trials   Clinical Data Management   Central Reference Lab     WHY INDIA - FAQ'S   01) What are the advantages of going to india for clinical research?   . Availability : With a booming Indian population, there is an availability of a large pool of treatment naïve   patients providing for a multiethnic and multiracial base. . Speed : Owing to the large base, patient recruitment is rapid in the Country thereby reducing the   development process. . Spectrum of diseases : The country has witnessed the presence of varied diseases that are not prevalent in   the West. Hence diseases such as multi drug resistant pneumonia, hepatitis B, diabetes and some forms of   cancer. . Economy : While all sectors are leveraging India's benefits with economy through outsourcing, the drug   companies too are tapping the potential with the country as they can save upto 30 to 50% overall on the cost   of conducting the trials here in India. . Trained investigators : The investigators in India are generally trained in the US or Europe and have gained   further exposure with Multinational trials based on the guidelines for GCP. . Regulatory compliance and standards : Based on the USFDA, any drug before it is released in the market   must first be tested on a global population. . Recruitment of subjects : Subject recruitment is the most common rate-limiting step in the drug development   process. Sponsors normally cannot reduce study timelines, without sacrificing the quality and incurring   increased cost. However in India, sponsors have the opportunity to recruit subjects quickly while maintaining a   high level of quality. Subject willingness is critical in these clinical trials and the compliance to undergo the full   process. In India with a large section of the population unable to afford their own treatments, opt for these   trials as they are assured on quality treatment and healthcare, which would have not been available   otherwise. Hence the subject return rates are amongst the highest in the world in India.   Global consultancy McKinsey & Co estimates that by 2010, global pharma majors would spend around $1-1.5 billion just for drug trials in the country. Pharma giants are also magnetized by India due to the fact that the country offers nearly 700,000 specialty hospital beds, 221 medical colleges and skilled English-speaking medical personnel.   02) What questions / objections have there been to outscourcing to india?   The clients are usually skeptical with regards to timeline for regulatory approval. With a dedicated regulatory consulting team who strive to meet the expected timelines, clients are bound to have a positive and encouraging experience.   03) Studies are run under GCP, what SOPs are in place to reflect them?   Companies like Manipal AcuNova have standardized Standard Operating procedures for Clinical trials, Clinical Data Management, Quality and Clinical Trial Supply Management. (The list of SOP can be provided if required)   04) Has the FDA reviewed or audited the sites?   FDA has been to India once and has audited sites in India. The FDA has provided a green signal for the same.   > next

Privacy Policy     Disclaimer