Clinical research - A golden oppertunity

India is the most exciting emerging in clinical research. It has the potential to play a central role in the next stage of the development of global profession. India offers a great market for the development of a robust clinical trials outsourcing, due to available resources required for clinical trial conduct.

Global pharmaceutical industry has gained an unmatched momentum in recent times making clinical Research as one of the most lucrative career avenue.  India is fast emerging as a preferred destination for conducting global clinical trials and is expected to conduct nearly 5% of all global  clinical trials in next 5 years . Demand of trained clinical research professionals is increasing as India is becoming a hub for global clinical trials. Involvement of qualified, trained clinical research professionals in efficient clinical trials is going to be vital for success as all pharmaceutical companies and CROs need to remain responsive changes in fast moving market …


Clinical research & clinical trials - An overview

Clinical research involves studies on human beings, in which the researcher directly interacts with human subjects. The process of Clinical research helps doctors and researchers to find new and better ways to understand, detect, control and treat illness A clinical research study is a way to find answers to difficult and quality of life questions.

If a research involves testing or studying a new drug or medical device to evaluate its safety and efficacy in Human beings, it is called a “clinical” There are several steps and stages of approval in the clinical trials process before a drug or device can be sold in the consumer market, if ever.

Drug and device testing whit extensive laboratory research which can involve years of experiments is animals and human cells. If the initial laboratory research is successful, research send the concern Ethical institutions and Regulatory Authorities for approval to conduct research and testing in humans.
Clinical trials are divided in four phases:

Phase I –To determine safety and pharmacokinetic / Pharmacod dynamic data using very less number of subjects

Phase II - To determine safety and efficacy of experimental drug/device using small number of target population.

 Phase III - To determine and confirm the efficacy of experimental drug/device using large number of target population. 

Phase IV- To determine safety of marketed drug/device in patients on treatment. It also involves study of efficacy of marketed products for other indication

Applications for are approved by concerned regulatory for each phase on the basis of available results and reports, to allow be conduction of clinical trial.