Safety in Japan

RxLogix was the first company to design the integrated Argus Global-Argus Japan process for a large pharma. Since then, RxLogix team has helped several very large to mid-size companies with their Argus implementation projects. RxLogix has the record of the fastest Argus Japan implementation for a top 50 global pharma.

In 2015, RxLogix Corporation and Hitachi Ltd. established a strategic partnership to offer innovative solutions in the Pharmacovigilance and drug safety space for life sciences companies operating in Japan. Hitachi not only helps sell and implement RxLogix' innovative PV software products but also collaborates with RxLogix global and Japan based team for Argus implementation, hosting and managed services projects.

The partnership leverages Hitachi’s tremendous expertise in Japanese PMDA Regulations, significant organizational scale, and local Japanese resources. RxLogix contributes in-depth Argus Safety suite expertise, extensive knowledge of global PV, implementation projects proficiency, data migration capability, and PV presence that includes the United States and Europe. Through the partnership, both companies mobilize their strengths to deliver PV and Drug Safety projects.


Tangibles and Intangible benefit you get when you use RxLogix Safety in Japan

Key Features

  • PMDA Regulations expertise
  • Argus Global – Argus Japan integrated and harmonized process design
  • End-to-end Argus implementation and training
  • State of the art PV Reporting platform in Japanese in addition to English, already selected by several global companies
  • Data Migration from safety systems such as Fujitsu Perceive, ARISj to Argus Safety Japan
  • Regulatory aggregate report setup e.g. PSR
  • 24x7 Japan based managed services
  • Hosted as well as on premise implementation services
  • Bi-lingual Japan based resources
  • Global resourcing model for global projects including the United States, Europe, and Japan
  • Global Project Management
  • Regular RxLogix User Group Conferences and Seminars in Japan
 

Key Benefits

  • Japanese PMDA PV Regulations compliant implementations
  • Fixed price, fixed time guaranteed Argus implementation for small and mid-sized companies
  • End-to-end offering for Japan at one place - products, implementation, hosting as well as managed services
  • Active collaboration with other Japan pharma users at RxLogix hosted conferences and seminars
  • Extensive local resources
  • Scalable capacity
  • Argus J and Argus expertise and best practices to set up the system
  • Local & global expertise
  • Local support & Help Desk

PMDA and E2B R3 Compliance

 

Achieve PMDA compliance using RxLogix PV Reports Japan

  • PMDA E2B R3 reports in HL7 format
  • PMDA Paper Reports are available without third-party BI tool
    • Form 1/2 – ICSRs
    • Form 3/4 – Research Reports
    • Form 5/6 – Foreign Action Taken Reports
  • PMDA Periodic Reports
    • J-PSR Form 3
    • J-DSUR
    • NUPR (Non-serious Unlisted Periodic Report)
    • SLL (Seiyakukyo Line Listing)
    • Defect Reports
    • Device Reports
  • Non-regulatory standard templates/queries for Japanese markets defined through projects/experiences with Japanese customers. e.g. Case Event Listing, Case Line Listing, Literature/Comments Line Listing, Lab Data.
  • All Japanese fields from safety systems for ad-hoc reports.
  • Full Japanese User Interface and multi-lingual capabilities.