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Undue delays in drug discovery development times, prolonged regulation-mandated testing and complex review processes, increasing R& D expenditure and intense industry competition are compelling pharmaceutical companies to look at contract research services from highly skilled destinations like India.
New compliance regulations such as GCP (good clinical practice) and GLP (good laboratory practice), along with EC, ICH and OECD guidelines are mandatory in clinical research and drug development processes. This has made drug research processes very time consuming and expensive for pharmaceutical companies. Pharmaceutical companies in the U.S. and Europe, where regulatory requirements are extremely stringent, are increasingly looking at outsourcing their research processes to external research bodies or 'contract research organizations' (CROs).
Contract research is the process of contracting out specific research activities and processes in a pharmaceutical company to an external research body. Some of the reasons for the growing popularity of contract research services are:
Contract Research Organizations are becoming important strategic partners for pharmaceutical companies as they help pharmaceutical companies to transition new drugs from concept stage to FDA marketing approval without the pharmaceutical company having to invest time, money and people for these services.
The following are covered under contract research services:
With the rapid growth in contract research, a large number of innovative pharmaceutical software solutions and products are being developed in India to meet the needs of the clinical research fraternity. Advanced contract research software tools are being developed that enable researchers to build, visualize, and analyze molecular models on your desktop. Software vendors are rising to the challenges to meet the increasing demand for clinical trial management software and clinical research data management software.
Software solutions for contract research include a wide variety of other tools and platforms such as:
India's total contract research revenues is expected to grow at 23.6% CAGR, touching USD 175 million by end 2010. "The rapidly evolving skill-set of Indian vendors in basic research and development have narrowed the skill-gap required for NCE research. This trend is one of the key attractors for western companies to outsource value added research services from India", believes Dr Raj Rajagopal, CCO KnowGenix.
Indian companies are providing excellent contract research services to global pharmaceutical companies. Some of the benefits that these companies find in contract research outsourcing to Indian service providers are:
Today, pharmaceutical companies are not asking 'whether' they should offshore contract research to India, but are instead deliberating on 'which phase' of the drug discovery process has to be sent to India so that they can best leverage the India advantage.
There are already 20 contract research organizations functioning from India providing a range of cutting-edge services. Global pharmaceutical companies stand to gain from the following factors by outsourcing research to India:
Indian contract research organizations are focusing on moving up the value chain by becoming 'preferred vendors' to a few global outsourcers rather than servicing a large number of companies. Contract research services from Indian research and pharmaceutical companies are mission critical research and developing proprietary technologies for global counterparts. Contract research organizations are expanding their geographical base and service portfolio through acquisitions, licensing arrangements and collaborative research.
Read more about the advances in Drug Development Technologies.