Product vigilance & safety


Artialis will ensure product vigilance and safety oversight during your trial with a team of experts including pharmacists, physicians, and life science professionals. Depending on your product,  a simple safety database included in the eCRF or a more complex and independent safety database will be built.

Artialis services cover :

  • Writing of safety section of study protocol

  • Safety Management Plan preparation

  • Safety database management, and reconciliation

  • Safety follow up, AE and SAE recording, and reporting

  • Expedited reporting (through EudraVigilance)

  • DSUR preparation and reporting 


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