Increasing and complex regulatory requirements, Globalization of Pharmacovigilance, Public and Politic expectations: The new proactive approach of Risk Management

If you want to ensure the safety of your products and the compliance to regulation you need:
  • Management of the safety for the clinical trials
  • Design of the safety plan
  • Training of the investigators and CRAs
  • Reception and treatment of the SAE declarations
  • Submission of the SUSARs to the Authorities
  • Periodical Safety Reports
  • SUSARs transmission to the investigators
  • Data Safety Management Board (DSMB)
  • Safety and data management databases reconciliation
  • Interface and support with the sponsorís Safety department
To learn more, please refer to our Safety section.