The focus on developing new treatments, expediting study timelines, managing regulatory requirements and optimising trial costs has prompted a surge in globalised clinical trials. This trend that has the potential to deliver significant benefits to patients, sponsors and society yet requires significant expertise to successfully mitigate the inherent operational risks global studies entail.

One sponsor required both operational expertise and robust project management capabilities to help them manage a global study involving sensitised IMP (Investigational Medicinal Product) and difficult-to-procure comparator products. However, several factors threatened the sponsor’s overarching objective of leading the fight against one of the most significant threats to humanity – antibiotic resistance.