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LifeSphere® Submissions Tracking

(Formerly known as agXchange OST)

Key Benefits


  • Allows affiliates to review and approve local submissions of safety cases
  • Lets affiliates add cover letters, translations and scientific assessments based on regional requirements
  • Fulfils local partner data reporting needs where appropriate

LifeSphere® Submissions Tracking – Enhancing Outbound Safety Submissions Tracking

LifeSphere Submissions Tracking draws on industry best practices to let pharmacovigilance departments standardize outbound safety submission tracking and provide a central overview of all submission activity. Cases are finalized in the central safety system and, once ready, can be automatically routed to affiliates for finalization and local drug safety report submission.  If a local affiliate does not need to be involved, routing of the case can be sent directly from the drug safety database to the relevant authorities.

Tracking local submissions is immediately visible in LifeSphere Safety Database, including submission decisions and dates.  Any follow-up communications needed before submission by the affiliate flows back through the processing chain to LifeSphere® Safety MultiVigilance, inbound case and receipt and ultimately back to the affiliate.

Leveraging open architecture, LifeSphere Submissions Tracking gives global companies a cost-effective and efficient approach to working with regional safety offices while maintaining transparent safety submission tracking into affiliate-level decision making and compliance metrics.

LifeSphere® Submissions Tracking – Enhancing Outbound Safety Submissions Tracking

LifeSphere Submissions Tracking draws on industry best practices to let pharmacovigilance departments standardize outbound safety submission tracking and provide a central overview of all submission activity. Cases are finalized in the central safety system and, once ready, can be automatically routed to affiliates for finalization and local drug safety report submission.  If a local affiliate does not need to be involved, routing of the case can be sent directly from the drug safety database to the relevant authorities.

Tracking local submissions is immediately visible in LifeSphere Safety Database, including submission decisions and dates.  Any follow-up communications needed before submission by the affiliate flows back through the processing chain to LifeSphere® Safety MultiVigilance, inbound case and receipt and ultimately back to the affiliate.

Leveraging open architecture, LifeSphere Submissions Tracking gives global companies a cost-effective and efficient approach to working with regional safety offices while maintaining transparent safety submission tracking into affiliate-level decision making and compliance metrics.

Key Benefits
  • Allows affiliates to review and approve local submissions of safety cases
  • Lets affiliates add cover letters, translations and scientific assessments based on regional requirements
  • Fulfils local partner data reporting needs where appropriate