Pragmatic Insights from Clinical Supply Management and EU Qualified Persons on How to Optimize Global Clinical Studies
Summary: Many APAC-based sponsors are planning to conduct trials in the European Union (EU). The EU regulatory framework around clinical trials and the role of the EU Qualified Person can seem complex and challenging, but are essential to understand if studies are to be successfully conducted in this important region. In addition, the day-to-day practice of clinical supply management (CSM) faces many challenges. Clinical trials have multiple moving parts that must be proactively managed, including clinical supplies that need to be prepared well in advance of the actual study start. In recent years, clinical studies have become more global and increasingly complex, involving a multitude of clinical sites and network depots spanning multiple countries and geographic regions, each with a unique set of challenges and requirements.