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Other denominations
Clinical Research Associate (CRA)
Description
The process for the approval of a new medication for human use is complex and time consuming. After pre-clinical investigation (in vitro and in animals), a new drug is tested on humans during a clinical trial using a methodology that is divided into three phases, until reaching the stage of post-marketing drug study and follow-up, or fourth phase. The whole process normally involves, at least, about 3,000 people, lasts between five and ten years (although this can vary a lot), and have a total cost of between 300 and 500 million euros. Registration requires presenting all the scientific documentation, including trial protocols and the results obtained. The clinical trial monitor or clinical research associate leads this project and is responsible for the clinical practices of a trial to approve a drug product, and ensures compliance with the requirements of the regulatory agency. They work in pharmaceutical companies or CRO (Contract Research Organizations) that offer to perform clinical trials for the pharmaceutical industry. Clinical trials usually take place in several centers and in different countries.
Tasks
© Barcelona Activa 2011
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