Services designed for the future of MedTech and its regulatory framework

Collect and manage clinical data for regulatory compliance.

Platform
Features TAILOR MADE FOR MEDICAL DEVICE studies

Support for Different Protocol Designs

Medical Device studies often require small adjustments in study designs depending on countries and EC approvals.

ISO 14155:2020 Adverse Event Reporting

ISO 14155:2020 and MDR compliant AE reporting. Packed with ready to use customisable templates

3-Step Study Builder

Enables quick and validated study setup that empowers clinical teams to be in full control of their activities.

Support for Dynamic Visits & Treatments

If your study subjects require one or many treatments with your device, you can use multiple activations for any visit event.

Nice to have features

Add-ons

  • eConsent

  • SMS ePRO Events

  • AE/SAE Module

  • Medication Module

  • Email Reporting

  • Translation Module

  • White Labelling

  • SMART-TRIAL API

  • Randomization

  • Monitoring Module

  • Study Notifications

  • SMART-TRIAL File Vault

Learn more about add-ons