You’re In Safe Hands

Our expert Pharmacovigilance and Drug Safety Services teams located across Europe are focused on safety in clinical trial and post-marketing activities. Their exceptional, and vast experience spans multiple therapeutic areas and combines a global approach with local knowledge to ensure safety and compliance.

From early phase clinical development through to post-marketing, and whether as a full-service solution or stand-alone pharmacovigilance clinical trials and post-marketing activities, our experience and understanding frees you up to do what you do best.

• Experienced team with a focus on clinical research and pharmacovigilance in drug trials and post-market with additional expertise in medical devices, combinations, immunotherapy, and gene therapy
• A Team of 70 Safety Experts in
  • Pharmacovigilance
  • Medical Device Vigilance
  • Cosmetovigilance
• Safety Data Exchange Agreement and Safety Monitoring Plan
  • SAE Forms
  • Pregnancy Forms
  • Narrative Templates
  • Submission Packages
  • Timelines for Expedited and Non-Expedited Cases
• Safety Reporting Training Material for the Sites and The Project Team
• Adverse Event management (full case management from reception to submission)
• Management of back-log cases
• Aggregate Safety Reports (DSUR, PSUR/PBRER, RCO) writing
• Expedited and periodic reporting to competent authorities (electronic or paper)
• Line listing and summary tabulation management
• Global and local literature search
• Monthly activity and compliance reports
• Safety signal detection
• Regulatory Intelligence
• EudraVigilance Registration
• xEVMPD Entry and Update
• Safety Database Management

Expert Team
With an average of 24 years of experience for each team member, we have successfully provided services to over 160 studies across the US and Europe.  We have strong local and global coverage with involvement in product approvals, including processes from early phase to NDA, and expertly managing EU CT safety submissions.