ArgusR Implement support

Argus Implement support

Drug Safety in Japan has, until recently, required separate database systems to handle different local processes and regulatory requirements.
With the advent of new generations of databases such as Oracle's Argus J, a single global database becomes reality.
We are bilingual Japanese safety specialists who really understand the Japanese safety environment and how to incorporate local Japanese Regulatory and process requirements in a global safety solution.

We can work with you to develop, rework or implement processes for case processing, regulatory reporting, signal management or risk management, utilizing industry best practices.

Based around the industry-leading Oracle Argus Safety suite we offer a range of services whether you are a new or existing customer.
Our Accelerated Argus methodology and toolsets will enable you to achieve significant time and cost savings on your new installation, including migration from your legacy system (whether in-house or another off-the-shelf system).
Similarly for existing customers we offer implementation of additional modules and an Accelerated Argus Upgrade program.

We have exclusive consultants team that have experiences in other companies, very depth knowledge about industry trend, regulatory trend especially in drug safety area of EU,FDA and MHLW.

1. Global Project Management
   Communicate with Relsys global, Relsys Japan, customer in English speaking sites. Develop project plan, meeting materials and minutes to support global meeting.
2. Validation & ERES requirements compliance consultation
   Support CSV and ERES requirements compliance documents creation in short time which is able to correspond to inspection/audit by FDA, EMEA and MHLW by offering assets (sample documents of another Company) and changing them to their specification
   
3. Business Process Development consultation
   Support construction of high quality global business operation documents (SOPs) where the Argus function can be used to its maximum in customer’s business process based on our assets.
   
4. Vendor Management
   Support managing system vendors who conduct system implementation and data migration from other system to Argus.
   

1. Global Project Management

Features of eCompliance

• We have lots of know-how by abundant experiences of Global System Implementation Support.
• We can offer total consultation service with depth knowledge of Business process and regulatory requirements.
• Consultants who are fluent in English and have abundant experiences use assets and proceed the project in directive style.
• We can create materials in English, interpret at the meeting and translate materials.
• We can offer consultation laid weight on customer’s profit and operational convenience from neutral position concerning products.
• We always lead the industry by giving seminars and disclosing information at website.