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Pharmacovigilance Data Migration, Database Support and High-Volume Case Processing for Six Oncology Products on an Expedited Schedule

Preview of case study about pharmacovigilance data services

UBC was selected by a mid-size pharmaceutical company to provide pharmacovigilance services for six oncology products. Data from two legacy vendors and multiple sources, including four specialty pharmacies and six license partners, had to be migrated to the new pharmacovigilance system.

Pharmacovigilance support services included:

  • clinical trial and post-marketing cases processing
  • global expedited reporting
  • preparation of periodic safety reports (DSUR, PSUR/PBRER)
  • database setup, configuration, hosting and maintenance
  • electronic migration of over 11,000 cases from two legacy vendors
  • safety regulatory intelligence
  • literature review
  • signal detection
  • project management activities

The rapid development of a PV team of 60 staff members was complete within the client’s expeditated timeframes for data migration and case processing. Our team of experts in global safety, pharmacovigilance, risk management, signal detection alongside our core technology suite resulted in no critical findings during an FDA and Medicines and Healthcare Products Regulatory Agency (MHRA) audit.

Case Study - Oncology Pharmacovigilance
To learn more about comprehensive pharmacovigilance capabilities head here.