We would be glad to support you with the processing of AE reports

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Initial Case Receipt

  • Minimal Criteria detecting
  • Serious Criteria detecting
  • Reporting Time Frame Allocation
  • Duplicate detecting
  • Local Case Register/Number
  • Cross-Check for product defects
  • Archiving according to Data Privacy Laws
=> Secure identification of ICSRs / SUSARs and Case registration

Initial and Follow-up reports of suspected adverse reactions are prepared in a standardised way according to your SOPs and according to the legal standards (e.g. CIOMS I form).

The CIOMS I form facilitates, in particular, the internal data exchange in your company for the Medical Review and the Quality Control.

If required, we can also support you with the individual case evaluations and the risk-benefit assessment.