Pharmacovigilance

Pharmacovigilance

Working with our highly skilled and experienced partners, Accord Research is able to provide clients with complex pharmacovigilance services for phase I – IV clinical trials.

These services include:

  • Consultation on study design
  • Study documentation review and update
  • PV Consultancy and Project Management
  • Medical monitoring
  • Serious Adverse Event Case Processing of Initial/Follow-up reports
  • Electronic safety  reporting via EudraVigilance
  • Support in EudraVigilance registration including providing person responsible for EudraVigilance
  • Safety Management Plan and Standard Operating Procedure development
  • Reconciliation of Serious Adverse Events
  • Regulatory reporting to Authorities, Investigators and Ethics Committees
  • Development of Data Safety Update Report (DSUR)
  • Development of Periodic Safety Update Report (PSUR)
  • Risk Management Plan (RMP)
  • Signal detection, validation and evaluation