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Clinical Research

 

Clinical Research is the study of a drug, Biologic or Device in human subjects with the intent to discover potential beneficial effects and/or determine its safety and efficacy. The product under Investigation is referred to as Investigational Product(IP).

-Clinical Research is patient oriented. It may be conducted in normal healthy volunteers or in people who have a specific disease or Illness.

-Clinical Research occurs after vigorous testing of the Investigational Product(IP) has been conducted in animals and in the laboratory setting. The sponsor must fulfill regulatory requirements prior to beginning  research in human subjects.

-The terms Clinical Study, Clinical Research, Clinical Trial and Clinical investigation are often used interchangeably.

Clinical Research Objectives:

-The objectives of clinical research are to evaluate the Investigational Product for Safety, Efficacy and Commercialization.

-If Clinical Research on the IP demonstrates the desired effect during the study, The sponsor can submit a request to the Regulatory Authorities for approval to market a drug in countries where it will be sold.