Clinical Trials
Clinical Trials
Complete support at the highest technical level in every step of the product lifecycle
Innovation
Experience
Knowledge
- Our Services -
- Preparation & revision of the Safety Data Exchange Agreement (SDEA)/Safety Management Plan (SMP)
- Management and follow-up of SAEs/SARs/Pregnancies
- Management and elaboration of queries to the center
- Management and follow-up of SUSARs and reporting in Eudravigilance
- Periodic reconciliations of SAEs/SARs/Pregnancies upon customer request
- Development Safety Update Report (DSUR) elaboration
- Safety Database maintenance
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