Monday, April 07, 2008

What is Clinical Research?.

A clinical research is a 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 safety and side effects during large-scale use. Clinical trials are conducted by pharmaceutical companies or contract research organisations (CRO's) on their behalf. It is this sector that is driving the growth in clinical research in India.

So, what does one need to become a part of this rapidly growing industry?

A B. Sc. degree is a must to enter this field. Ideally the industry is looking for science graduates from pharmacy, medicine, life science and bioscience. Within bioscience too there are various other fields such as botany, zoology, biochemistry and genetics. Anybody who fulfils these criteria can join the industry.

Individuals with prior work experience of 2-3 years are preferred, but like the BPO industry, there is a dearth of trained professionals here too. Thus, with the right qualifications finding a job in clinical research should not be a problem.

Job Profile.
Clinical Research branches off into various categories at the entry level.

The most common entry-level position is that of a Clinical Research Associate (CRA). The role of a CRA is varied,
They are key participants in the design, implementation and monitoring of clinical trials

They shoulder the responsibility of planning and implementing all activities required to conduct and monitor complex clinical trials and ensure that Good Clinical Practices are followed.

They assist in preparation of presentations and manuscripts of scientific meetings and technical journals and attend scientific/professional meetings and training courses as appropriate.
BIOSTATISTICIAN are those who,
Perform statistical programming, design, and analysis for clinical trial projects. Planning, coordinating and providing statistical analyses, summaries and reports of studies is also a part of their job profile.

In addition they are responsible for New Drug Applications and Biological License Applications submissions.

CRM are Clinical Research Managers,

They supervise design and writing of protocols, case report forms and informed consent forms for clinical trials. They ensure that Case Report Forms are reviewed in a timely fashion and submitted to the data management group.

There are other posts too such as Clinical Research Coordinator, Business Development Manager, Clinical Research Investigator, Clinical Data Manager etc.

There is high demand for trained professionals in this field; the pay package is impressive at the entry level.
Freshers can expect a pay packet of around three lakhs or more per annum.

If you have a master's degree backing your qualifications, then the amount is almost doubles.

Clinical research is an industry where experience counts, thus the longer you are in this field; higher the salary you can expect.

Growth Prospects.
There are various growth opportunities along the way for those willing to learn. For those interested in serious research work, a PhD is the ideal solution. There are post graduate degrees and diploma's offered by various colleges which come in handy to enhance one's career prospects. Specialization in branches of pharmacy, life sciences, biochemistry will be useful.

Studying further will also help one in bettering their current job profile. For instance doing a masters will enhance the job prospects of a CRA to become a Project Manager. Similarly a PhD in a related discipline is needed to become a Medical Director.

According to industry reports,

India is the second largest pharmaceutical market in Asia growing by more than nine per cent annually. According to a report, there are more than 50,000 jobs in clinical research in India .

Lack of experience is no longer a hindrance, and companies are hiring from other streams too. With the influx of multinationals setting up research facilities here, the industry is poised to grow exponentially.

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