Crema's Approach  CR simplified for Life science students
Clinical Research simplifiedClinical Research is an organized trial of a new drug conducted on human beings to determine its safety and efficacy.
Out of the 5,000–10,000 leads screened, only 250 enter pxe-clinical testing, out of which just five enter Clinical Testing. Out of these five molecules, only one is approved by the US FDA for use in humans Source: Tufts Center for the Study of Drug Development. Clinical Research is conducted in four phasesPhase I : It is the first stage of testing a new drug in healthy human volunteers. A small (20-80) group of healthy volunteers are selected for Phase I research. This phase includes trials designed to assess the safety tolerance, pharmacokinetics, and pharmacodynamics of a drug. Phase II : Phase II trials consist of a larger group (100-300) and is carried out amongst patients/volunteers, after the initial safety of the study drug has been established in Phase I. This stage determines how well the drug works and helps to assess the dosing requirements and the drug efficacy. Phase III : Phase III studies are performed on large patient/volunteer groups (1,000-5,000) depending upon the kind of medical condition that is being studied. This stage is aimed at assessment of how effective the drug is and to obtain additional safety data to support marketing claims for the drug. Phase IV : Phase IV known as Post-marketing Surveillance Phase involves the safety surveillance and ongoing technical support of a drug after it receives permission to be sold. This phase is conducted over a much larger patient population and for a longer duration than all the earlier three stages. It is designed to detect any rare or long-term adverse effects.
Drug Development takes approximately 15 years from basics to humans at a cost of approximately USD 1 billion. The Drug Development undergoes In-Vitro and In-Vivo processes as explained in the diagram above. Making an impact the World over : Global pharmaceutical industry has gained an unmatched momentum the world over, making Clinical Research one of the most lucrative careers in recent times. There couldn’t be a better time for Clinical Research. The global market is estimated to be worth over USD 52 billion. There are more than 2,50,000 positions vacant with attractive salaries. And with a dramatic increase in the number of trials being conducted worldwide, the demand for Clinical Research professionals is ready to reach an all-time high. India - At the forefront of Clinical Research revolution : India has an easy access to a large, diverse and therapy-naïve population with vast genetic diversity ready to undergo clinical trials. Also, India is home to a vast reserve of knowledge and resource base and is strategically located in the arena of global clinical research and trials. India’s potential as a favourite outsourcing destination has led many global pharma companies to set up Clinical Research businesses here. Advantage India Key factors contributing to India’s emergence as a hub for Clinical Research:
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