Outsourcing Clinical Trials in India
The present day economic conditions has made it crucial to outsource business in the field of medical science, especially in the case of pharmaceutical and biopharmaceutical business. This has been on the rise with the outsourcing of clinical trials that constitutes a crucial part of the drug development process. A research study named “Booming Clinical Trials Market in India” highlights about the trends of Indian clinical trials that has been expected to grow at a CGAR beyond 30 percent during the years 2000 and 2012. With this expansion that is anticipated, India is expected to become the leader in medical tourism and become the global clinical trial hub.
This report also highlights leading pharmaceutical players and the clinical research organizations (CRO’s) conducting clinical trials globally by locating patients who qualify for the trials. This process is reported to be simpler in India than any other Western destination. Few other essential aspects such as the cost-effective nature if the trials and the prominence of ailments have also facilitated the growth of medical researches. The report further reveals certain controls, for instance the absence of sufficient medical staff and inappropriate IPR security that has halted the growth. Hence, for clinical trials to become a successful phenomena in India it is crucial to look into these issues and resolve them.
Indian CRO’s have been carrying on clinical trials for a while now. They have strategic partnerships with esteemed medical hospitals and institutions nationally. Selected CRO’s also have global alliances. All this results the CRO’s in possessing critical databases on multiple therapeutic areas and other proprietary and diagnostic trials.
Indian CRO’s are known for conducting Phase II – IV trials. They have their own research programs and project implementation such as pharmacokinetic analysis, clinical pharmacology, and bio-analytical method development carried on by a team of qualified medical co-coordinators and research associates. They follow a 360 degree approach towards clinical trials thereby making sure that the sponsors benefits from a vast range of services as listed below :-
* Pharmacy Services that assures a strict adherence to GCP and other related international regulatory requirements
* Feasibility Studies
* Clinical Trial Supplies and Management
* Bio Statistics
* Project Management
* Clinical Monitoring
* Volunteer Recruitment and Planning
Bio Studies too are yet another segment of services offered by the CRO. A range of bioavailability and bioequivalence are conducted in multiple centers in compliance with the global regulatory policies that are supervised by an independent quality assurance segment.
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