We would be glad to support you with the processing of AE reports
Initial Case Receipt
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.