The new Adverse Events Reporting Module

Compliant, Customizable & Consistent


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


Use the SMART-TRIAL Survey-4