Reliance Clinical Research Services (RCRS) is now addressing the clinical research services market in USA and Europe. RCRS is mandated to emerge as an India-based, world-class contract clinical research services organization. RCRS is part of the Reliance Group of Companies, India's largest private sector company, and a component of the life sciences initiative of Reliance.
Commenting on the development, Mukesh Ambani, chairman and managing director, Reliance Industries Limited, said, "Reliance Clinical Research Services initiative is one aspect of Reliance's transformation from a manufacturing organization to a knowledge and services driven enterprise."
RCRS provides services in project management, clinical operations, site management, biometrics (data management and biostatistics), medical affairs (pharmacovigilance and medical writing), regulatory affairs, animal studies, quality assurance, molecular diagnostics, ICH-GCP training, archival facility and drug storage and supplies.
"The value proposition of RCRS is built around a strong knowledge base and network in the medical domain, full service project planning, conduct and management of trials throughout India, in-house molecular diagnostic support and in-house Phase - I and pre-clinical toxicity ability", said Dr. Rajat Goyal, vice president, Reliance Clinical Research Service.
RCRS is currently conducting several studies for clients based in the USA, UK and Middle East. RCRS is working for indications in Oncology, Burn wounds, Cardiovascular, Endocrinology, Nephrology, Gastroenterology, Infectious diseases and Vaccines.
Cost of clinical trials in USA and Europe have skyrocketed, and recruiting qualified, therapynaive patients, i.e. patients who have not received any prior treatment, can be extremely time consuming and delay completion of these trials for months or even years. Many healthcare companies, both large and small, find doing clinical trials in India an attractive option.
Completing clinical drug trials and product development in India could be up to 75 per cent faster. As per Rabo India Finance, although the average cost of doing Phase I, II and III drug trials in US are $20/50/100 million respectively, in India they are 50-60 per cent of the same.
In recent years, India has created a favourable environment for clinical trials. India signed the WTO agreement (fully effective in 2005) to alleviate issues related to protection of Intellectual Property. Regulatory laws have been updated to conform to the global GCP guidelines. All medical facilities have been mandated to meet the GCP procedures and training support of medical personnel necessary to achieve this goal provided. India has provided exemptions for import duties on clinical trials products and eliminate the procedural hurdles that were prevalent in the past.
India has very large pool of highly trained physicians, nurses, and technical personnel and numerous world-class medical facilities that meet the global requirements for clinical testing. Many major pharmaceutical companies have already successfully used clinical trials' data from India for US FDA NDA (Federal Drug Authority New Drug Application) submissions. The broadly developed information technology infrastructure in India provides added advantages to ensure speedy conduct of studies and flow of information/data from the sites to the sponsors' databases.
As a result, India is seeing a rapid growth of clinical trials. The setting of a large, diverse, and therapy-native population, low cost for technical services, and use of English as the primary business and medical language is ideal for completing trials rapidly and cost efficiently.
"RCRS expects to leverage these strengths with its value proposition to deliver world-class clinical research services to global pharmaceutical, biotechnology, medical device and nutraceutical organizations", said K.V. Subramaniam, sr. executive vice president, Reliance Industries Limited.