The biggest risks to a global study occur long before the first patient is enrolled.

The illusory ideal for every sponsor running a global study is to manage one programme built around a single protocol, data package and regulatory strategy that runs universally across every market and region. The reality is far more complex because a global trial is not simply one study happening simultaneously in several places. It is composed of several regional programmes, each running under their own regulatory systems, site relationships and often their own timelines, that a sponsor likes to perceive as a single study.