Swiss CRO moves into Indian clinical trials market

Switzerland-based contract research organisation PFC Pharma Focus has set up an Indian subsidiary with the help of Excel Life Sciences, a US firm that specialises in running trials in India.PFC India will be based in New Delhi and offer clinical trial support services such as study planning, monitoring, audit and data management services to biopharmaceutical companies and other CROs.India is fast becoming a global hub for clinical research, with the number of trials carried out each year growing by 50% a year, according to PFC. That view ties in with a report published by RNCOS earlier this year, which found that at present around 2% of all clinical trials in the world are carried out in India. That proportion is expected to more than double to 5% by 2012.The rapid growth is expected occur on the back of India's huge pool of potential trial participants, ease of recruitment and cost savings that could slash the cost of trials by 50-75% compared to the US or Europe.The new PFC India venture "combines the strengths of a long standing and successful European CRO" with ELS' "local expertise," PFC and ELS said in a joint statement.Their New Delhi unit will allow them to "offer our clients access to a large diverse patient population as well as to a significant number of patients suffering from rare diseases", said PFC's chief executive and co-founder Dr Kurt Pfister.Despite India's potential, there have been some brakes on growth, including some scandals relating to unethical trials, delays in approvals, inadequate protection of clinical data and a lack of Good Clinical Practice-compliant sites and investigators. Last year, for example, the industry suffered a knock to its reputation after an investigation was launched into 49 infant deaths seen during trials carried out by the All India Institute of Medical Sciences (AIIMS) in New Delhi. The Indian government recognises that clinical research could be a major growth industry in the country, and has been taking steps to improve oversight of the sector. Last week it implemented a scheme whereby all companies conducting clinical trials in the country are required to list studies in a registry operated by the Indian Council of Medical Research (ICMR).The register has run for a couple of years on a voluntary basis, but is now a legal requirement. It is freely accessible to the public. "The Drugs Controller General's office of India is stepping up its compliance standards," commented Dr Vijai Kumar, president and chief medical officer at ELS.At the same time, "pharmaceutical companies are requesting a high level of service, preferably from an experienced and established brand," he added.

Source: www.pharmafocus.com