Phase I-III Clinical Trial Pharmacovigilance within the EU

Specialized on the needs in pre-marketing authorization.

Safety Data Handling

  • MedDRA Coding
  • WHO ATC Coding
  • Safety Data Analysis
  • Query Raising
  • Safety Data Review

EMA/Eudravigilance Handling

  • EMA Sponsor Registrations
  • Responsible Person for EudraVigilance
  • EudraVigilance XEVMPD Submissions
  • EudraVigilance ICSRs Submission

Medical Monitoring

  • 24/7 Study Safety Officer Service
  • Medical reviews of ICSRs, DSURs
  • Intermittent PV reports
  • Safety Data Analysis

Pharmacoviglance Consulting

  • Reviews of Clinical Trial Protocol, DSUR, IB
  • EU Regulatory Requirements
  •  PV Requirements
  • Clinical Trial Conduct
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