The Clinical Trials Process
What are the 7 Deadly Sins of Quality Assurance and Quality Control? Download our free QA QC eBook now to find out! Clinical trials play an extremely important role in helping pharmaceutical companies get their products to market. They are designed to ensure the safety and efficacy of new products before they are marketed to the public and they are needed for companies to be granted a licence for their drugs. Approval has to be sought by the regulatory authorities in the individual countries where the pharmaceutical clinical trials are being conducted before they can begin. In the United States, this is the Food and Drugs Administration, while in the UK, the Clinical Trials unit of the Medicines and Healthcare Products Regulatory Authority is tasked with the responsibility. Pharmaceutical clinical trials can be carried out either in-house or by clinical research organisations (CRO), which are also sometimes known as contract research organisations. The Association of
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