SAE Management
SCiAN’s SAEPRO system is a natural extension of EDCPRO and meets stringent requirements for collecting, validating and reporting of serious adverse events across multiple studies in a clinical program.
SCiAN works with medical professionals in the study indication to review SAE reports and assess seriousness and expectedness with respect to industry reporting requirements.
The functionality of SCiAN’s SAEPRO system includes:
- Customize -Host – Manage Safety (SAE) Databases
- Collect, process and assess SAEs
- Determine regulatory reporting requirements (seriousness and expectedness) of adverse drug reactions
- Prepare reports for regulatory agencies (CIOMS I, MedWatch)
- Disseminate reports to Sponsors and other parties
- DB transfer in .XML, SAS or other format