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El objetivo

  • Client was involved in a merger situation with data from two different partners (Oracle AERS and Empirica Trace)
  • The Oracle AERS case processing team had been eliminated and medical support has been cut significantly
  • Ashfield Pharmacovigilance provided case management and PV services to the Trace partner

Nuestro enfoque

  • We developed a comprehensive strategic plan to ensure continuation of case processing while maintaining both databases
  • We also proposed a strategy that ensured on-boarding activities proceed smooth and within timelines
  • The client was also provided PV services for combined companies, incl. signal detection, PSUR/PADERs, & REMs support

Los resultados

  • Currently more than 3,000 cases are being processed annually for the Trace partner
  • On-boarding activities for the Go-live for Oracle AERs processing date progressed efficiently within requested timelines
  • Since then all datasets have been merged into one singular database
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