FAQS

June 7, 2005.

October 27, 2008.

CRO (Clinical Research Organization) normally refers to a body for accepting the consignment of aspects of the medical drug development business in medical-related fields.

It indicates corporations that can substitute for and support some of the business and other activities related to clinical trials during the medical drug development stage, and clinical trials after sales of medical drugs when they are being developed by pharmaceutical companies.

CRA (Clinical Research Associate) normally refers to a clinical development monitor (or clinical trial monitor). It indicates a person who monitors whether a clinical trial during the medical drug development stage is being performed in compliance with the Pharmaceutical Affairs Act and other related regulations, the clinical trial standard operating procedure, and the protocol.

Monitoring is the central activity in the development of new drugs. A Clinical Research Associate (CRA), the person in charge of development, visits the medical institution and formally explains the clinical trial contract, explains the clinical trial drug to the doctors, describes the protocol, checks the status of compliance with the protocol, delivers the clinical trial drugs, requests cooperation with the clinical trial (integrates the clinical cases), ensures data reliability and collects the data.

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