Aris Global Software Pvt. Ltd.

ARISj

The only proven 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 system, is the perfect solution for organizations working or partnering with Japanese companies and affiliates. Supporting all domestic reporting requirements, ARISj enables you to establish a worldwide platform for pharmacovigilance.

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 of the leading Japanese pharmaceutical companies, enabling them to meet both their domestic MHLW and international reporting obligations. Read the Guerbet Group customer success story, for one proven example.

Arisj

As with all Aris Global products, ARISj is available as a hosted solution on the agOnDemand platform. For more than four years, agOnDemand has been providing best-in-class, cloud-based services to life science companies to help them meet their regulatory requirements without the pressure of maintaining sophisticated IT infrastructures.

The only proven Japanese pharmacovigilance system

ARISg and ARISj can be deployed in a decentralized environment or with one central database. All configurations, workflows and data entry templates are set up once and easily shared by all global affiliates. Together with ARISg , global companies can support all international reporting obligations. Other key features include:

  • Fully Japanese language enabled
  • Fully integrated with ARISg
  • Comprehensive support for MHLW requirements
  • Support for latest expedited & periodic reports as specified by MHLW
  • Integrated MedDRAj browser, support for MedDRAj versioning
  • Full support for Japanese hospital codes, products and clinical studies
  • Integrated with agXchange for electronic submissions
  • Supports all domestic reporting obligations
  • Successfully deployed at leading Japanese pharmaceutical companies
  • Advanced query and ad-hoc reporting capability
  • Optional deployment in a centralized or decentralized environment

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 additional 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

"We selected Aris Global because we found it to be the only company providing a solution capable of meeting our requirements of an integrated, comprehensive global pharmacovigilance system with proven Japanese language and regulations support."

Mr. Nassim Belhadj,
Project Manager, Pharmacovigilance, Guerbet Group