A truly global pharmacovigilance program requires collaboration and the sharing of case information between all major ICH regions including Japan.
ARISj, a Japanese language enabled drug safety system, is the perfect solution for organizations working or collaborating with Japanese companies and affiliates. It supports reporting of adverse reactions in accordance with the Japanese Ministry of Health, Labour and Welfare (MHLW)/ Pharmaceuticals and Medical Devices Agency (PMDA) requirements. Together with ARISg , ARISj is the only proven solution for international companies wanting to establish a global pharmacovigilance program. ARISj has been successfully deployed at many global pharmaceutical companies, enabling them to meet both Japanese and international obligations for adverse event reporting. (Read the Guerbet Group customer success story, for one customer success story.)
As with all Aris Global products, ARISj is available on premise or on demand (SaaS)
ARISg and ARISj can be deployed in a decentralized environment or with a single global pharmacovigilance database. All configurations, workflows and data entry templates are set up once and easily shared by all global affiliates. Other key features include:
ARISj is successfully deployed at many of the leading Japanese pharmaceutical companies.
ARISj is fully integrated with ARISg for global compliance and offers the following benefits: