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Pharmacovigilance

Your agency reporting requirements + our pharmacovigilance expertise

No matter what part of the drug development cycle you are in, you need to keep a sharp eye on the way your safety data is collected and reported. Envigo employs a specialized pharmacovigilance group committed to supporting the set up and management of your PV reporting system and to ensuring you meet agency reporting requirements.

We deliver pharmacovigilance support in both clinical and peri- / post-marketing settings, and we have the necessary experience to assume the role of responsible person for eudraVigilance and qualified person for pharmacovigilance.

With extensive changes currently occurring within the pharmacovigilance legislation and regulations, we are well positioned to navigate you through the requirements for post-marketing pharmacovigilance, including preparation and maintenance of the pharmacovigilance system master file.

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From protocol review through to receipt, processing and reporting of serious adverse events (SAEs), we are able to provide tailored support for clinical trials, particularly focusing on:

  • First-in-human and other early phase studies
  • Blinded studies
  • Unblinded studies with robust systems in place to ensure that the distribution of unblinded data is limited to the appropriate parties
  • E2B compliant ICSRs
  • Periodic line-listings
  • Development safety update reports
  • Periodic safety update reports
  • Training – an up-to-date overview of current safety reporting requirements, delivered at your premises
  • SOPs – provision and management of SOPs appropriate to your organization’s needs
  • Registration of sponsor companies to EVG
  • Receipt and processing of serious adverse events
  • MedDRA coding of event terms and production of CIOMS / MedWatch forms
  • Reporting of SUSARs to regulatory agencies and research ethics committees / IRBs
  • Aggregate safety reports