Today in the highly competitive clinical trials sector, if you don’t spot potential risks before they become a danger to the patient, and a regulator can prove you had the information to mitigate them, you are liable to face one or more of the following: closure of your business unit, a prosecution case that could lead to a jail sentence, and personal responsibility for the serious illness or death of a patient. Never before has it been so important for Clinical Trials teams to be alert for signals that point them in the direction of possible risks.

Regulators now expect a more risk based approach, and a framework such as this is proof you are taking it and them seriously. Regulators are changing the way they audit to reward a more proactive, structured approach.