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Safety Data Exchange Agreements (SDEAs)

Leading Technology and Medico-Legal Experience for Full SDEA Creation, Updates, and Archiving

ClinChoice’s specialists have experience reconciling and updating SDEAs across all the operating geographies of the marketing authorization holders and other partners.

Our Services Include:

  • Digitization of Paper SDEAs
  • Reconciliation of SDEAs
  • Creation of Global SDEA Templates
  • Coordination and Authoring of ew SDEAs
  • Review of Existing Audits for Assignment of Responsibilities and Updates of Terms
  • Maintenance of Active SDEAs
  • Authoring of SOPs for the Governance of SDEAs