• 24 July 2006
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Rewarding Profession

Rewarding Profession With India becoming a signatory to TRIPS

Rewarding Profession
With India becoming a signatory to TRIPS, and clinical trials being mandatory to be conducted as per ICH GCP norms, new career opportunities are available for thousands in clinical research.

Dr SK Gupta

Director General and Dean
Institute of Clinical Research (India), New Delhi

Clinical research involves organized research conducted on human beings and is intended to provide adequate information on drug use – its safety, efficacy and adverse effects, if any. It is a thrust area for development of new drugs, formulations, delivery systems, dosage regimens, therapies and more. With the advent of high throughput screening, drug discovery programs have speeded up, making clinical evaluation as the rate-limiting step towards final product development.

Scope

With India having committed to the WTO TRIPS (Trade Related Aspects of Intellectual Property Rights) agreement, the face of the Indian pharmaceutical industry is set to undergo a complete transformation. As per the current scenario in the next few years, many key patents will expire. With new patent laws having come into effect, it will no longer be feasible to replicate drugs from abroad. Hence, innovation will be the key. Major pharmaceutical companies are looking to bring in new pharmaceutical products off the laboratory bench and onto the pharmacy shelves. In order to accommodate this, the industry is all set to upgrade from mere pre-clinical research and development to clinical trials work. Also, every new drug needs evidence from clinical research to support its launch. Thus, whether it is a new chemical entity or an existing drug that is being marketed for new indication, clinical studies have to be conducted. Similarly, launch of new formulations, drug delivery systems or even new fixed dose combination requires clinical data before it can be marketed. Hence, it is obvious that the area of clinical research holds immense scope and promise, as without the supporting data, drug launches are not feasible. An in-depth analysis of the industry also shows that unless serious measures are taken, the clinical research sector will face major lack of professionals, which means clinical research is definitely the next big career as a rewarding profession. What's more, a job in clinical research offers the following incentives too:

  • Excellent remuneration packages

  • Fast-track career growth

  • Breadth and depth of roles and job functions, enabling one to select the area that best matches one's skill sets and interests

  • Opportunities to work overseas.

Demand

India possesses a significant potential to be the global hub for clinical research. It is also being increasingly recognized as a quality player and preferred partner for global clinical trials. India has several attributes for clinical trial development, such as:

  • Large and diverse patients pool for conducting clinical trials.

  • Availability of medical, pharmacy and science graduates.

  • Excellent infrastructural facilities.

  • Comparative cost advantage.

  • Changes in the patent laws.

According to McKinsey report, by 2010 more than 50,000 professionals will be required in the field of clinical research in India alone. Many pharmaceutical and clinical research organizations have already come forward to unlock the vast potential India has and, are conducting clinical trials in India. This means science, pharmacy and medicine graduates can look forward to exciting and rewarding career opportunities in clinical research.

Careers in Clinical Research

  • Clinical Research Associate

  • Clinical Research Coordinator

  • Clinical Research Investigator

  • Study Coordinator

  • Data Manager/Biostatistician

  • Regulatory Affairs Manager

  • Clinical Trials Auditor

  • Clinical Project Manager

  • Clinical Research Manager

  • Business Development Manager

  • Drug Safety Associate

  • Medical Writer

Trained clinical research professionals will also be in demand abroad. Today, there are more than 2,50,000 positions vacant worldwide. And salaries vary from a minimum of $40,000 per annum for a clinical research coordinator to almost $1,00,000 per annum for a business development manager.

To keep pace with the global advances in the field of clinical research, one needs to join a training institute that can impart innovative and intellectually challenging education at the highest academic standards.

By Dr SK Gupta

 

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