Foresight Group is the most experienced company for implementing Argus J, having completed implementations for many top 50 pharmaceutical companies as well as offering services to small to medium business (SMB) within Japan seeking a future proof system that supports both domestic and global requirements. We have performed more Global-Japan process design and system implementations than any other company.
Argus Safety Japan adds a Japanese user interface with the additional Japanese fields and regulatory requirements necessary to support Japanese requirements. The product fully supports reporting to the PMDA. The system automatically translates code values from Japanese to English, and vice versa. Furthermore, Argus Safety Japan includes MedDRA and MedDRA J browsers and supports the Japanese Drug Dictionary. Users can view a case in English, Japanese or both via a slit screen model.
The ability to pool drug safety data into one integrated drug safety system for both global and Japan produces a more streamlined process with lower cost of compliance, lowering risk. For companies with a presence in Japan, Argus Safety Japan (Argus J) serves precisely this purpose, aligning seamlessly with Argus Safety in an integrated system to manage worldwide drug safety information. It eliminates double data entry, reduces translation efforts, accelerates the process of managing and reporting safety cases and allows for signal detection and analysis across all cases with a single solution.
Our success in implementing Argus J is driven by seven key factors:
Successful harmonization of global and Japanese business processes driven by resources who understand both global and Japanese regulations and requirements. All process hand-off points are clearly defined. Business processes and the associated Argus workflows are aligned to ensure cases are not delayed or have unnecessary handling steps.
A strong understanding of both Argus and Argus J – because Argus J cannot be implemented without also configuring the global elements of the core underlying system. Leveraging our unequaled experience helps to reduce implementation time significantly.
Harmonization of data entry conventions between Japan and global. Since Argus Safety Japan is simply a module of Argus, all code lists and values are shared between global and Japan. The code lists are harmonized to ensure that Japanese requirements can be met.
Data migration of data from both global and Japanese safety systems such as Fujitsu Perceive, ARISj and H-P Clinical Works. We know how to properly merge duplicate cases between global and Japan into a single case as part of the implementation of a single integrated system used by global and Japan.
Superior knowledge of PMDA reporting requirements.
We have designed, developed and validated many Japanese custom reports for Argus J — so we know how to meet unique Japanese requirements and have the resources to configure Argus J for aggregate and other reports plus build any additional custom Japanese reports required.
Experienced full-time employees in each major region required (United States, Europe, India and Japan), with many bi-lingual English and Japanese speaking resources located in Tokyo, US, Europe and India. We have on-site resources in bi-lingual employees in Japan during each project working with our global team.
Our history of success speaks for itself. With our prior experience and knowledge, we know exactly what to do and how to go about doing it. Our employees are not learning on the job at your expense.