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)