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Pharmacovigilance / Medical Device Vigilance

Our safety team takes care of the safety management in clinical trials on medicinal products and medical devices. The services range from compliant process planning to the handling of documentation and notification requirements all the way to data analysis and reporting of safety data in various formats. In particular:

Drug trials:

  • SAE management (safety desk) for sponsors including query management, tracking and quality control, communication with sponsor and study centres, and complete GCP-compliant documentation
  • Pharmacovigilance database
  • SUSAR notification to ethics committees and investigators
  • Electronic SUSAR notification to the competent authorities
  • Preparation of case narratives and patient narratives
  • Annual safety reports (DSUR)
  • Back office for data monitoring committees (DMC)

Medical device trials:

  • SAE management (safety desk) for sponsors including query management, tracking and quality control, communication with sponsor and study centres, and complete ISO 14155-compliant documentation
  • SAE reporting to competent authorities in Germany and abroad

 

Contact

Any questions, interested in our services? Contact us!

Tel.: +49 7071 9992-0