Clinical Safety

Sponsor customised clinical safety management

  • Safety management planning
  • SAE / AE handling (documentation, requesting, reporting)
  • Medical analysis
  • SAE / AE data management
    (tracking, data entry, query management)
  • Spontaneous adverse event reporting
  • Medical writing (narratives, CIOMS, annual safety reports)
  • Regulatory dictionary coding
  • Safety reporting to investigators / Ethics Committees / Authorithies
  • Reconciliation service
  • Literature services (search, review, summaries)