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How to Ensure the Safety of Temperature-sensitive Clinical Trial Medication

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Patient safety is the top priority of every clinical trial. Therefore, it is vital the investigational medicinal product (IMP) dispensed to the patient is both the correct drug and dose, and is in good
condition. Many clinical trial drugs have a strict stability profile; the acceptable temperature range in which the drug must be stored to be deemed safe is often restricted. As such, it is critical that trial sponsors are able to control and monitor the temperature conditions of the IMP. It is also vital that sponsors have visibility of any excursions prior to dispensation, to ensure no risk to patients. Tim Gilbert of PAREXEL shows how sponsors, site staff and patients can have full confidence that their IMP is safe to dispense.

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