SAE Database

Our AMEDON SAE Database

Our severe adverse events (SAE) Database solution was developed according to the ICH E2B Revision 3 Standard and considers the EU case safety report business rules.

It is designed to ensure a straightforward workflow from documentation of incoming SAE/SADE reports to generated EVWEB input files during clinical trials and post market surveillance.

Our solution also fulfils all requirements to directly generate and complete CIOMS reporting PDFs.