Meeting Regulatory Requirements in Japan: Customised IXRS® Manages Patient-Specific Drug Orders

Filling patient-specific drug orders requires thinking beyond an organisation’s standard supply chain processes. For one sponsor undertaking a program of trials across 30 countries, Almac had already re-configured IXRS® with new features and functions to enable individualised ordering and customisation of the investigational drug for each patient upon enrollment. But Japan’s regulatory environment posed unique challenges. The country-specific solution now manages and tracks the flow of drugs through an additional sub-depot for quality control before they are forwarded to the patient site—while capturing all related audit trails of what was shipped, when, how, and where.