Career Opportunities in Clinical Research :

Posted: Jan 25, 2011 |Comments: 0 |

Clinical Research is a Multi national, Multi billion and Multi disciplinary Industry

Clinical Research is an organized trial of a new drug, conducted on human beings to determine its safety and efficacy. In other words Clinical research is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products, and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relief of symptoms in a disease.

Four Phases in Clinical Research:

Once a treatment is tested in the laboratory, it can undergo human testing. Clinical trials are conducted in a series of four steps or phases.

Phase I

It is the first stage of testing a new drug in healthy human volunteers. For this a small group of healthy people (20-80) is selected to test its safety tolerance, pharmacokinetics and pharmacodynamics of a drug.

Phase II

The drug or treatment is given to a larger group of people (100-300) to see if it is effective, after the initial safety of the study drug has been established in phase I. This phase helps to analysis how well the drug works and helps to assess the safe dosing range.

Phase III

Phase III studies are performed on larger group of people (1,000-5,000) to confirm how effective the drug is and to obtain additional safety data to support marketing claims for the drug.

Phase IV

Phase IV known as post-marketing surveillance phase involves safety surveillance and ongoing technical support after the drug receives permission to be sold. This phase is conducted over much larger group of people and for longer duration. This trial may occur after the drug or treatment has been approved for use by the FDA.

Growing Opportunities in Clinical Research:

Clinical research industries are quite attractive and growing exponentially in the past few years. It has opened large number of career opportunities to medical, pharma and all interdisciplinary fields. There are more than 360 big and small CROs in Mumbai, Delhi, Gurgaon, Hyderabad, Bangalore etc. Unlike the other industry which is completely dependent on other countries, Clinical Research Industry is not completely dependent. India has major giant Pharma companies who themselves have their own CRO establishment.

Opportunities in Clinical Research

India is fast emerging as a "sweet spot" , as compared to most emerging markets, with a robust 31 % p.a growth over the last 4 yrs.

Big Pharma today carry out more than 60% of clinical trials in India through their captive centres.

India is ranked third among emerging markets and is growing the fastest in its number of industry sponsored phase II - III sites

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