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Safety Handling

Clinical Trial Pharmacovigilance

The Clinical Company provides the pharmacovigilance responsibilities for your trial. Our EudraVigilance trained Responsible Person (safety coordinator) guarantees the collection, review and reporting of safety information within the required timelines.

Our Drug Safety services include:

  • Collection and review of Serious Adverse Events (SAEs)
  • Follow-up of SAEs until complete SAE
  • Forwarding of SAEs to sponsor
  • Querying sites in case of missing information
  • Tracking SAEs and FU SAEs in a pharmacovigilance database for the specific study

  • Preparing of an unblinded study specific Suspected Unexpected Serious Adverse Reaction (SUSAR) report, through unblinded access of our safety coordinator
  • Forwarding of SUSARs to Sponsor
  • Expedited reporting of SUSARs to Competent Authorities via EVweb (Eudravigilance reporting tool)
  • Expedited reporting of SUSARs to Ethics Committee and Investigator sites
  • Distribution of Line Listings to Ethics Committee and Investigator sites

  • Preparation and sending of Development Safety Update Report (DSUR) to Sponsor
  • Submission of reviewed DSUR to Competent Authorities and Ethics Committee
  • Distribution of complete DSUR to Investigator sites

 

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Please contact our Business director for more information in how we could support in managing a clinical project.

+32 474 760 460e.cuppens@theclinicalcompany.com