Clinical Trials and International Contract Research Organizations
July 17th, 2008 at 10:12am Under Health
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 with the help of a pharmaceutical contract research organization or CRO. Pharmaceutical research and medical device companies can slash their costing by taking their clinical trials to countries like Latin America, China and India. India has a huge population of treatment naïve 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 the drugs and get them out cheaply.
Clinical Trials and Clinical Research is an essential step in taking any drug to the market. Clinical research 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 by various clinical research services and remote study management before it can be safely tested on human beings. The process is strongly regulated by FDA (Food and Drug Administration) with FDA clinical trials being done. On an average it takes 1.2 billion dollars and around 12 years to bring a new drug to the market with the correct pharmaceutical research.
Global Clinical Trials & Research Organization (GCTRO), a CRO based in the United States, enables pharmaceutical, device manufacture, and biotechnology 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 TRIPS, Indian pharmaceutical companies can no longer produce generics of the drugs discovered by the US pharmaceutical companies. 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.
“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 speedy way,” says Vijay Kumar the president of GCTRO. For more information visit their website at www.gctro.com.
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 for a clinical research associate to rapidly move in the direction of finding cures for diseases with a new insight and knowledge database. Now the challenge is to make the best of this vast database, available to the clinical research community. Pharmaceutical contract organizations are now looking to take testing to other data management and clinical research facilities so that different subject matter expert companies can come together and find new solutions to the human diseases.
For more information, please visit www.gctro.com
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