Safety Database Services

Foresight uniquely has the mix of Global and Japan, business, and technical resources required to deliver Global (English) or Japanese solutions either standalone or integrated into a single system with a harmonized workflow and process for both Global and Japan. MouseGlobeEuropeClear320H

We are skilled in the intricacies of Argus/Argus J and ARISg™ and corresponding data mart and business intelligence tools including Argus Insight, Argus Mart, Cognos™, OBIEE and Business Objects™. We assist with:

  • Implementation and upgrades of safety databases
  • Requirements and design of the infrastructure for premise based systems (alternatively, we can host your system and/or your development environments)
  • Design the configuration for the new system
  • Implementation of E2B R2 and E2B R3 reporting and import to/from health authorities and license partners
  • Implementation data marts as well as custom reports (in English and Japanese)
  • Performing any necessary data migration(s) from global and/or Japanese legacy systems
  • Provide business transition and change management services to ensure a successful implementation. We work with your business leaders to develop the new business process and workflow
  • Identify SOPs that need to be created or updated and update/author SOPs as required (in English or Japanese)
  • Assist with development and delivery of training to your safety, business and IT organizations worldwide in English or Japanese
  • We provide complete validation services in both English and Japanese ranging from validation management to script authoring and execution. We also write user requirements (URS), functional requirements (FRS) and all other CSV deliverables per your QA standards (e.g., IQ, OQ, PQ, VSR, trace matrix)
  • We leverage our worldwide delivery model to provide cost effective validation services and to enable rapid delivery by “following the sun” within each work stream

Finally, we recognize your safety database is not the only system required to manage your PV department. Foresight has extensive experience with integrating safety databases with custom and commercial systems both upstream (e.g., case receipt from affiliates and call centers), downstream (e.g., signal detection and risk management), and with other departments (e.g., clinical EDC systems such as Medidata Rave®).