Clinical Trials and International Contract Research Organizations
Clinical Trials and International Contract Research Organizations Every disease in the modern world is being researched continuously to find a cure, better cures and various other methods of controlling or maintaining them to be safe for humans. Pharmaceutical research and medical device companies can slash their research cost by taking their clinical trials to countries like Latin America, China and India. India has a huge population of treatment na´ve diseased people, state of art infrastructure, and highly trained doctors and professionals including people to do clinical data management.
This ensures a shorter timeframe to market for the drugs at a reduced cost. Clinical Research is an essential step in taking any drug to the market. Clinical trials are conducted to allow safety and efficacy data to be collected for new drug development or devices.
After the target molecule shows promise in the lab tests, it is tested on animals before it can be safely tested on human beings. The process is strongly regulated by FDA (Food and Drug Administration) in USA or corresponding regulatory authorities of other countries. On an average it takes 1.2 billion dollars and around 12 years to bring a new drug to the market. Global Clinical Trials & Research Organization (GCTRO), a CRO based in the United States, enables pharmaceutical and Medical Device manufacturing companies to conduct Phase I-IV trials in India.
GCTRO has a large network of highly trained and experienced physicians specializing in clinical trials and project management. As per the Intellectual property rights and the TRIPS Agreement , Indian pharmaceutical companies can no longer produce generics of the drugs discovered by the US pharmaceutical companies by merely changing the manufacturing process. Thus it becomes essential for the Indian Pharmaceutical companies to do their own research and we are already witnessing a steep rise in that. US pharmaceutical companies can take advantage of the ensuing infrastructure for Clinical Trials in India to reduce their cost and time of the research for new drugs . US pharmaceutical companies saving money by doing their trials faster and cheaper using contract research organizations in India should adopt a dual cost structure and make these drugs available in India at an affordable price.
Additionally the price of the drugs in US should also come down and would be in reach of millions of Americans who can't afford to pay for them presently. One major leap in modern times have been the Human Genome Project, the primary goal of which was to make a series of descriptive diagrams of each human chromosome at increasingly finer resolutions. This opens doors for a lot of unique opportunities to rapidly move in the direction of finding cures for diseases with a new insight and knowledge database. "Gradually we intend to move up the food chain and start contributing in the research of new molecules for Drug Development using the excellent resources in India.
We want to be an integral part of system in bringing the drugs to the market in the most cost efficient and rapid way," says Vijay Kumar the president of GCTRO. For more information visit their website at www.gctro.com.
Vijay Kumar, CEO, GCTRO Inc is author of article written on Global Clinical Trials(Phase I-IV) & Clinical Trials in India. For more information, please visit :www.gctro.com
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