• End to end safety case processing for SAEs, AESIs or other safety events
• Safety report generation, distribution and submission through a submission portal
• Periodic and Annual safety report generation and submission
• Extensive experience working in client or 3rd party safety databases
• Expertise in a variety of therapeutic areas such as oncology, CNS, and rare disease
• Safety services for marketed products include:
  • Serious and non-serious case processing and regulatory reporting
  • Periodic safety update reports (PSUR), annual and quarterly report preparation
  • Signal detection services
  • Literature search services
  • Registry, observational, phase IV and evidence