Keeping in mind the present day economic condition, outsourcing business in the medical sciences, has gone up especially in biopharmaceutical and pharmaceutical business.
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Rise in the outsourcing of clinical trials in india
1. Rise in the Outsourcing of Clinical Trials in India
Keeping in mind the present day economic condition, outsourcing business in the medical sciences, has gone up
especially in biopharmaceutical and pharmaceutical business. This has increased with the outsourcing of clinical
trails that comprise an essential part of drug development process. The research study "Booming Clinical Trials
Market in India" talks about the clinical trials in India that has been estimated to expand at a CAGR over 30 percent
during the years 2010 to 2012. As this growth is being eagerly anticipated, India is being estimated to be the
highest growing medical tourism and clinical trial hub in the world.
The report talks about the eminent biotech and pharmaceutical players and also the CRO’s that have been working
towards carrying out clinical trials globally by finding patients that qualify for these trials. This process is said to be
easier in the Indian sub-continent as compared to any Western destination. Other factors for instance the cost-
efficient nature of the trials and the prevalence of the disease have also been promoting the medical trials. The
report also highlighted certain restraints such as the absence of adequate trained medical staff, weak IPR
protection and few others that are hindering the growth of the market. Therefore, in order to make the Clinical
trails in India flourish, it is necessary to look into these concerns and resolve them.
CRO’s in India have been conducting Clinical Trials for quiet sometime now. They have strategic alliance with
prominent medical institutions and hospitals all over the country. Some of them even have global link ups and tie-
ups. Therefore, CRO’s have got the access to databases that highlight multiple therapeutic areas and other
diagnostics and proprietary trials.
The CRO’s in India also conducts the Phase II –IV trails. Furthermore, they have their own research programs and
other project implementation for instance pharmacokinetic analysis, clinical pharmacology, and bio-analytical
method development that are conducted by a team of qualified research associates and medical co-coordinators.
They out forward a 360 degree approach towards the clinical trails ensuring the sponsors the advantages from a
vast range of services as listed below :-
Pharmacy Services that assures a strict adherence to GCP and other allied international regulatory
requirements
Feasibility Studies
Clinical Trial Supplies & Management
Bio Statistics
Project Management
Clinical Monitoring
Volunteer Recruitment & Planning
These apart, Bio Studies too are another segment of services provided by the CRO’s in India. A vast range of
bioavailability and bioequivalence are done in various centers complying with the global regulatory requirements
that are further supervised by an independent quality assurance segment.
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