Comply with international standards on Adverse Event Reporting
While we waited in anticipation for the 2020 update of the ISO 14155 standard, the SMART-TRIAL team was working hard on implementing updates to the Adverse Event module. The newly updated AE/SAE module offers:
✓ Regulatory Compliant AE/SAE Workflow ✓ Ready-to-use Regulatory Compliant Templates ✓ Customizable AE Forms ✓ Clear Overview of all Safety Events ✓ Automatic Email Notifications
Comply with ISO 14155 & MDR
Get more information on how you can customize the AE module to your study needs
