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Expansion of Indian Clinical Trials

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India has been working hard to make its name in the global pharmaceutical arena as a preferred hub for eminent global enterprises to conduct clinical trials. It is a challenge for both the private and government sector to establish a healthy balance between trade and ethics.

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									                                Expansion of Indian Clinical Trials
India has been working hard to make its name in the global pharmaceutical arena as a preferred
hub for eminent global enterprises to conduct clinical trials. It is a challenge for both the private and
government sector to establish a healthy balance between trade and ethics. Indian government has
been playing an active role in standardizing the regulations by governing the way clinical trials are being
conducted. The private sector comprising of clinical research organizations (CRO) and pharmaceutical
companies have succeeded in carrying out global clinical trails in India.


At the same time, there has been an increased awareness of good and healthy clinical practice
requirements, a strong desire for internal acceptability of research conducted outside India. This in
turn inducted constructive changes in the attitude of Indian medical technicians towards contributing
for clinical trials. Investigators are keen on taking part in clinical trials that adhere with GCP and are
interested to abide by the protocol constraints.


Leading Indian CRO’s have introduced research programs that assist in executing high-end and
innovative models on clinical pharmacology, pharmacokinetic analysis, and other bio-analytical
methodologies that are conducted by selected teams of well-trained clinical co-coordinators. They
follow a 360 degree approach concerning clinical trials and makes sure that the sponsor benefits from a
selection 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
    ●   Biostatistics
    ●   Project Management
    ●   Clinical Monitoring
    ●   Volunteer Recruitment & Planning


Clinical researches and trials comprises of a portfolio of research domains that assist in disease
treatment and drug development. Other sections that fall under it are medical writing, biometrics, bio
analytical services, and many more. In the recent past India has seen the emergence of numerous CRO’s
that are responsible in carrying out numerous clinical trials and other studies, such as the Phase I Study.


According to a joint study conducted by Federation of Indian Chambers of Commerce and Industry and
global consultancy Ernst & Young, India today takes part in more than 7 percent of all international
Phase III and 3.2 percent of all international Phase II trials. In addition to that, a report presented by
RNCOS, a market research firm it is noted that the Indian clinical trials outsourcing market is estimated
to expand at a compound annual growth rate beyond 30 percent during 2010-2012 and by $600 million
by 2012.


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