Key Features/Benefits

  • Allow local affiliates to place their “seal of approval” on local submissions of safety cases
  • Provide capabilities for local affiliates to add cover letters, translations, scientific assessments, local causality techniques, etc. based on regional requirements
  • Allow additional local forms and documents to be submitted by local affiliates
  • Fulfil local partner data reporting needs where appropriate

Background

Despite global standards, there has always been a level of divergence between different authorities when it comes to the transmission and reporting of safety cases.  To ensure compliance often the best method to handle local variations in standards is in fact via the local affiliates who fully understand the local obligations and commitments required.  However, often these affiliates have no access to the central safety database and require manual processes or when do have access, find the process both complex and inefficient.

agXchange™ - Outbound Safety Submissions Tracking

agXchange™OST enables companies to standardize outbound case submissions while leveraging local knowledge for local requirements.  When cases are finalized in the central safety system and are ready for reporting, they can be automatically routed to individual affiliate inboxes for finalization and local submission.  At this time, the local affiliate can review the proposed submissions, document the reporting decision, add cover letters and translations, select source documents or attachments, track communications and even update the local assessment in the E2B xml prior to submission.  A flexible system, OST allows defined subsets of cases to be routed this way – if a local affiliate does not need to be involved, routing of the case can be direct to its destination bypassing the local affiliate review process.

Tracking of local submissions in OST is immediately visible in ARISg/ARISj to ensure there is a central overview of all submission activity, and includes submission decisions and dates.  Similarly, if there are any follow-up communications needed before the affiliate can agree to submit a case, this can flow backwards through the processing chain to ARISg/ARISj, agXchange IRT and ultimately back to the reporter.

agXchange OST provides global companies with a cost effective and efficient approach to leveraging their regional safety offices while maintaining full transparency into affiliate-level decision making and compliance metrics.

safety investigator reporting

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