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Emerging Trends in Contract Research Industry in India

  • Date Submitted: 01/05/2011 08:35 AM
  • Flesch-Kincaid Score: 32.5 
  • Words: 1384
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1. Introduction
A clinical trial is a particular type of research that tests one treatment against another. It may involve either patients or people in good health, or both. Small studies produce less
reliable results so studies often have to be carried out on a largenumber of people before the results are considered reliable. For this purpose the concept of CROs must be understood to ascertain whether the treatments under study are safe, have any side effects, and whether the new treatments are better than available standard treatments. A Contract Research Organization (CRO) is a service organization that provides support to the pharmaceutical industry. CROs offer clients a wide range of “outsourced” pharmaceutical research services to aid in the drug andmedical device research and development process. The Services offered by CROs include: product development, formulation and manufacturing; clinical trial management; clinical, medical and safety monitoring; preclinical, toxicology, and clinical laboratory services for processing trial samples; management, biostatistics and medical writing services for preparation of an FDA New Drug Application (NDA), Abbreviated New Drug Application (ANDA); regulatory affairs support; and many other complementary services. The clinical studies take up most of the time spent in the R&D division of a Pharmaceutical firm; the major expenses incurred in the new drug discovery process are mainly limited to the Phase I, II and III of the clinical trials. As drug discovery is a tedious and time consuming process involving exorbitant expenses on part of the research organizations, CROs may help in screening of thousands of compounds over a period of 10–12 years, costing millions of USD, before bringing into realization the successful launch of a product in the market.

2. Contract research organizations (CROs) in India
At present, talking in terms of India, the Clinical Trials Industry occupies a very small pie of the global market...

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