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Meeting regulatory requirements in Japan: Customised IXRS® manages patient-specific drug orders

But in Japan, the 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.

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 Clinical Technologies had previously re-configured its Interactive Response Technology (IRT), IXRS® with new features and functions to enable individualised ordering and customisation of the investigational drug for each patient upon enrolment.

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