Abstract
Conducting clinical trials is an extremely complex undertaking in one country let alone one involving multiple countries. In most cases, the trials are conducted in multiple countries due to strategic reasons in order to obtain regulatory approvals for the drug product or device under study. This has many aspects which include: intellectual property for the new product or device under study, the regulatory requirements in order to obtain market approval for the particular product or device, and last but not least cost considerations. This paper focuses on conducting clinical trials in order to obtain market approval outside the US.
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