Clinical research is the studies that conducted mainly to evaluate safety
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Posted On :
Oct-19-2010
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Article Word Count :
428
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Clinical research is the studies that conducted mainly to evaluate safety, quality and effectiveness of investigational products, drugs, medical devices or medical procedures on humans in a strictly scientifically controlled setting.
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Clinical research is the studies that conducted mainly to evaluate safety, quality and effectiveness of investigational products, drugs, medical devices or medical procedures on humans in a strictly scientifically controlled setting. The scope and demand for clinical research is seems to be increasing rapidly in the recent years. It is one of the fastest growing industries in the world and it is considered as one of the most auspicious and well paid professions.
The pharmaceutical companies undertake the trials in order to know the product completely and then only release it to the customers for use it. Choosing an appropriate partner for the process of drug development is the most critical step in clinical research.
There are many companies which provide effective, comprehensive and most innovative services for your clinical Trial needs through its association with highly qualified and experienced investigators. And they conduct services in four different phases:
Phase I trials – This is the first time the new drug is being directed to small number of volunteers under the supervision of a doctor. It is conducted mainly to determine whether the patient body accepted the drug or not.
Phase II trials – This is the second step in which the medicine is administered to a group of approximately informed patients to find out its effect and also to check whether the drug produce any side effects to the patients.
Phase III trials – In this phase the group is between 1000 and 5000 to analyze the results. If the result is positive then the data is provided to the licensing authorities for getting commercial license.
Phase IV trials – This is a examination phase after the medicine is made available to doctors who start to prescribing it. Once it is examined, the effects are monitored on thousands of patients to help identify any unanticipated side effects.
The clinical research services offers various medical writing services that includes designing case report forms, statistical report preparation, protocol authoring services, protocol preparation, IND/NDA/ANDA preparation, Investigators handbook preparation, standard operating procedures preparation, subject recruitment documents, clinical study report preparation, package inserts preparation, informed consent preparation and so on.
The data management services offered by clinical research services offering addresses the recent regulatory requirements for any compliance and encompasses various principles. They provide customized solutions aimed at reducing the data management costs, portability of data for further analysis and accountability and improvement in data quality.
These are some of the clinical research services
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Article Source :
http://www.articleseen.com/Article_Clinical research is the studies that conducted mainly to evaluate safety_38271.aspx
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Author Resource :
Soniya Gurg writes content about Clinical research services, Drug safety associate,Clinical research organization,contract research, contract research organisations, contract research company. For more information visit at: http://www.qsi.in/.
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Keywords :
Drug safety associate, Clinical research services, Clinical research organization, contract research, contract research organisa,
Category :
Business
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Business
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