subject: Clinical research in Bangalore [print this page] Clinical research in Bangalore Clinical research in Bangalore
As we all know that the medicines are created in the factories and before moving it to the market, they undergo many approval tests. For this approval test they need Clinical Research Professionals and this is what the Clinical Research means.
These Professional's are the one who make shore that the no wrong medicine, which will be harmful to human race will not at all released in the market.
The term clinical research refers to the entire biography of a drug/device/biologic, in fact any test article from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety toxicity if applicable and efficacy, if possible at this early stage) are studied.
The eight fundamental standards that guide clinical research are:
The risks of a study must be minimized through sound research design and methodology
Risks must be reasonable relative to the anticipated benefits of the study
The selection of research volunteers must be equitable and without bias
Informed consent must be obtained from the person participating in the study
The consent language agreed to and the process for obtaining consent must be documented carefully
Research patient privacy and confidentiality must be protected
Ongoing safety of research volunteers must be adequately monitored
Vulnerable patients such as children must be adequately protected
These studies are usually conducted in tightly controlled clinics called CPUs (Central Pharmacological Units), where participants receive 24-hour medical attention and oversight. In some diseases in which the therapy under study is known to be too toxic for healthy subjects (some cancer medications, for instance), phase 1 trials are performed in patients with diseases to test these parameters.
In the European Union, the European Medicines Agency (EMA) acts in a similar fashion for studies conducted in their region. These human studies are conducted in four phases in research subjects that give consent to participate in the clinical trials.
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