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File Photo: K. Ananthan

Vast scope: An employee at work at a clinical research organisation in Coimbatore. —

Clinical Research is a scientific study of the effects, risks, efficacy and benefits of a drug before it is launched in the market. These trials are undertaken at various stages and studies are conducted even after the launch to monitor safety and sid e-effects. Clinical trials are conducted by pharmaceutical companies or clinical research organisations (CRO’s) on their behalf.

Today, there are about 200 clinical research players in the country, says Ananda Padmanabhan, Director, Consortium Clinical Research Private Limited.

The India Brand and Equity Foundation states a McKinsey report saying the global clinical trial outsourcing to India in the pharmaceutical industry is estimated to be worth Rs.4,920 crore by 2010.

“This upward trend creates a great demand for trained manpower,” Mr. Padmanabhan says. However, the profession is still relatively new in India and requires certain specific cognitive and communication skills, he adds.

Consortium Clinical Research Private Limited is setting up an institute in Coimbatore offering post graduate diploma in Clinical Trial Management and Regulatory Affairs.

The basic qualification required to be trained in clinical research management is a B.Sc in life sciences. Medical doctors, pharmacists, nurses and lab technicians can also pursue this career branch.

Career opportunities for students who have completed a B.Sc Microbiology, Biotechnology, Botany, Zoology, or a B.Pharm or B.Sc Nursing is limited. Training in clinical research can widen their prospects. They can find suitable job options in pharmaceutical companies, clinical research organisations, as medical statisticians or undertake freelancing work. Statistical data maintenance is also an emerging area, Mr. Padmanabhan says.

The training will provide a basic knowledge of clinical research, expertise in handling medicines, formating for clinical tests and a thorough grasp of the regulatory affairs.

The institute, which is likely to come up by next year, will offer separate programmes for doctors, pharmaceuticals, nurses, fresh science graduates. Candidates would have to undergo an entrance test and an interview. Campus recruitments would be organsied by the institute.

The duration of the course is four weeks for full-time batches and 24 weeks for Sunday batches. For a weekday batch, it will be 20 weeks.

Currently, the institute will start its first batch on December 20 for 25 students at Sugunapuram near Kovaipudur.

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