Powerful add-ons to enhance your PMCF activity or Clinical Investigation

Build your study toolbox by selecting features based on study needs

Adverse Event Module

The only ISO 14155:2020 & MDR Compliant EDC fully integrated in the eCRF

  • MDR compliant AE reporting
  • Customise to fit your needs
  • Flexible access & permissions
  • Automatic notification to users & sponsors
  • Real time overview and event progress tracking 
  • AE specific data export

eConsent 

SMART-TRIAL offers a regulatory-compliant and subject-friendly method for recruitment of subjects that allows them to sign informed consent digitally.

  • Comply with CFR21 part 11 and EU standards for electronic signature
  • eSignature methods based on location preferences

Upload large files to the SMART-TRIAL File Vault

Collect and manage large files from your study with the SMART-TRIAL file vault. A secure way to store large files such as MRI scans, CT scans, EKG recordings and more. The File Vault is fully integrated with SMART-TRIAL and enables you to quickly collect and organise these files in your study.

Communicate with the SMART-TRIAL API 

The SMART-TRIAL API supports two way communication to push and pull data directly to/from your study. Hassle free, secure and fast transfer of any data into a SMART-TRIAL study of your choice.

  • Supports multiple devices
  • Integrates with 3rd party applications
  • Data export for internal storage

Randomization Module

SMART-TRIAL provides block randomisation with variated block sizes. It is simple to set up and use, fulfilling all quality requirements that are relevant for this particular function.

Medication Module

Collect vital information on concomitant medications and even link them with your Study AE/SAE reports.

  • Standardise reporting on concomitant medication
  • Standardise reporting on IMP
  • Maintain an overview with medication accounting

Translation Module

Let subjects fill out questionnaires in their own language. All data is stored in the primary language and can be exported with the primary Study language that you choose.

SMART-TRIAL supports 28 languages

Study Notifications

Improve your productivity with study notifications. Use the prompts to go into the system only when your attention and action is required.

  • Email notifications 
  • Webhooks

White Labelling

Make SMART-TRIAL your platform with custom Logo and labelling.

SMS for ePRO

Enable SMS send-out for quick responses from subjects and improve compliance.