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Product vigilance & safety
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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