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GCP breaches must be met with hammer blows

This article was originally published in Scrip

Executive Summary

It is nothing short of a disgrace when a company fails to adhere to good clinical practice in a drug trial. Such disregard for regulations can result in a waste of effort, time and money, not to mention the delayed entry of a potentially important drug into world markets. Furthermore, the negative impact on the safety profile of a product hardly inspires confidence in a trial sponsor and potential marketing authorisation holder.






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