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A clinical eye
WITH A WIDE ARRAY OF CHOICES BEING THROWN UP,SCIENCE GRADUATES
FROM BIOTECHNOLOGY,ZOOLOGY,BOTANY,MICROBIOLOGY AND LIFE SCIENCES
CAN MAKE A CAREER IN CLINICAL RESEARCH.THE BUSINESS IN INDIA IS
EXPECTED TO GROW AT A COMPOUND ANNUAL RATE OF AROUND 31 PER CENT
BY 2012
KETAKI LATKAR
Do you ever wonder how medicines actually make it to pharmacy
shops Do they travel from the production lines straight to the
market What is their credibility quotient As a matter of fact,
pharmaceutical companies are a gigantic but unsung industry which
is intricate and has different verticals. Post-production
pharmaceutical companies need to procure a validation for their
medicines by going through different government laws and
regulatory approvals in order to begin marketing. The capital
involved in this process is enormous and so are the opportunities
for research and development.
Clinical research is the scientific study of the effects, risks,
efficacy and benefits of a medicinal product. These are carried
out prior to the release of the medicine in the market. These
trials are undertaken at various stages and studies are conducted
after the launch of a new product to monitor its safety and
side-effects . Clinical trials are conducted by pharmaceutical
companies or Contract Research Organisations (CROs).
Clinical trials involving new drugs are commonly classified into
four phases. Each phase of the drug approval process is treated as
a separate clinical trial. The drug-development process normally
moves through all four phases over many years. If the drug
successfully passes through Phases I, II, and III, it usually gets
approved by the national regulatory authority for use in the
general population. Phase IV are 'post-approval' studies.
Eligibility
B Sc degree is a must to enter this field. Graduates in
biotechnology, zoology , botany, chemistry, microbiology or life
sciences or medical practitioners (MBBS/BDS) are eligible to
choose an M Sc in clinical research.
No age is a barrier for pursuing clinical research, but surely,
the age range allowed to pursue training in clinical research
depends on a number of factors, with safety always first in mind.
Career Prospects
Clinical research as a career can be extremely challenging and
rewarding. It is an area that is relatively less saturated and
therefore has room for innovation and opportunities. Entry level
positions in this arena usually are of clinical research
associates and there is also scope of diversification in the other
departments of data management , pharmacovigilance (science of
detection, assessment, understanding and prevention of adverse
effects, particularly long-term and short-term side effects of
medicines) and business development.
Future Prospects
According to a recent research, the clinical trials' outsourcing
market in India is expected to grow at a Compound Annual Growth
Rate (CAGR) of around 31percent between 2010 and 2012. Presently,
the market is characterised by the dominance of phase II, and III
trials, which currently hold more than 80 per cent of the market.
This scenario is expected to remain intact in future as well.
Institute Watch
Bombay College of Pharmacy Academy for Clinical Excellence
Institute of Clinical Research Clinical Research Education &
Management Academy There are also some other institutes that offer
a range of diploma courses and MBAs in clinical research.
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Quality
