Outsourcing of Contract Clinical Research
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Posted On :
Feb-24-2011
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Article Word Count :
361
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A clinical research is the biomedical research that addresses the assessment of new pharmaceutical and biological drugs, medical devices and vaccines in humans.
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A clinical research is the biomedical research that addresses the assessment of new pharmaceutical and biological drugs, medical devices and vaccines in humans. A contract research organization is also called contract clinical research organization and it is primarily a service organization that provides support to the pharmaceutical and biotechnology industries in the form of outsourced pharmaceutical research services. Clinical trials are driven by these associates of clinical research. A research associate ensures compliance with clinical site activities, clinical trial protocol, makes on-site visits, reviews Case Report Forms and communicates with the clinical research investigators.
These associates are usually required to possess an academic degree in Life sciences and need to have a good knowledge of Good clinical practice and local regulations. The contract clinical research organization industry is relatively young. Most of the top CRO industry participants were founded between the late 1980’s and the mid 1990’s, as the pharmaceutical industry first began to recognize outsourcing as an effective cost-reduction strategy. The CRO industry emerged mainly in the late 1990s when pharmaceutical R&D efforts became more complex and competition in rapidly growing therapeutic areas increased. In order to be competitive and realize profit margins, pharmaceutical companies began outsourcing activities to other organizations.
CRO firstly entered in bio-tech industry and then took a role in research and development, expanding from drug discovery to drug manufacturing and clinical trials. Outsourcing is influential particularly in the pharmaceutical industry, as the success of a large pharmaceutical company depends on competence in fields as diverse as combinatorial chemistry, computer integrated manufacturing and marketing medicines directly to consumers. Due to the success of outsourcing in processes such as Data Management, Database Management, Database Development and Medical Coding. Moreover, contract clinical research will become more and more important for pharmaceutical companies if such pressures are likely to increase in future and connection between CRO’s and drug developers will expand.
As both domestically and internationally, the CRO market is expanding rapidly besides the economic downturn of last few years. Therefore, it is necessary to effectively evaluate the potential impact of outsourcing by understanding the CRO selection process and the key factors in CRO selection.
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Article Source :
http://www.articleseen.com/Article_Outsourcing of Contract Clinical Research_53820.aspx
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Author Resource :
For more insights and further information about Contract clinical research, FDA Pharmcovigilance, Pharmacovigilance solutions,Drug safety surveillance, Pharmacovigilance in uk, Clinical research Professionals, Drug Safety consultant, Volume 9a pharmacovigilance, Clinical research uk and Pharmacovigilance services visit our site http://www.qsi.in
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Keywords :
Contract clinical research, FDA Pharmcovigilance, Pharmacovigilance solutions, Drug safety surveillance, Pharmacovigilance in,
Category :
Health and Fitness
:
Health and Fitness
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