Aris Global Software Pvt. Ltd.
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ARISj

The Only Proven, Globally Compliant Japanese Pharmacovigilance System

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.)

Arisj

As with all Aris Global products, ARISj is available on premise or on demand (SaaS)

Enabling a Global Pharmacovigilance Program

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:

  • Comprehensive support for Ministry of Health, Labour and Welfare (MHLW) reporting requirements
  • Fully Japanese language enabled
  • Comprehensive support for MHLW requirements
  • Support for latest expedited and periodic safety reports as specified by MHLW
  • Integrated MedDRA and MedDRAj browser
  • Full support for Japanese hospital codes, products and clinical studies
  • Superset of ARISg that can be used stand alone, or together with ARISg, on the same global database
  • Integrated with agXchange ESM for electronic submissions
  • Japan-compliant E2B, with J-Items support
  • Integrated with Japanese-interface versions of modules for inbound receipt and triage (IRT) and outbound submissions tracking (OST)

The only proven Japanese pharmacovigilance system

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:

  • Ensures compliance with Japanese reporting obligations for expedited and periodic submissions
  • Provides an efficient mechanism to share safety data worldwide with its multilingual capabilities
  • Helps eliminate redundant data entry in a global environment
  • ARISj offers all the benefits of ARISg, with a localized and enhanced Japanese experience