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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Almac Clinical Technologies
Almac Clinical Technologies is here to help the biopharmaceutical industry bring new therapies to those in need by empowering clinical trial sponsors to proactively manage sites, patients, and clinical trial supplies through our industry-leading Interactive Response Technology (IRT) and expert consultancy.
Almac Clinical Technologies is uniquely positioned to unlock new efficiencies in the clinical supply chain and to help achieve greater predictability in your projects and programs.
Our professionals are dedicated to delivering high-quality Interactive Response Technology (IRT) solutions, dependable professional services, and reliable customer service. Our expertise, energy, and commitment have earned us a reputation as a trusted ally in the drug development process.