Simplifying MedTech Compliance

SMART-TRIAL is designed controlled according to MedTech industry software standards, IEC62304 and ISO13485. Hosted in one of the world's most secure server environments by Microsoft Azure.

Ready to use Templates

Streamline the process of documentation and compliance with SMART-TRIAL’s SOP templates and validation templates.

14155:2020 Compliance

We ensure that you can be compliant with the industry latest standard on GCP for Medical Devices.

Clinical Data Management SOPs

We deliver ready-to-use SOP templates that you can customise to your own QMS or study protocol.

Ole Kjeldsen
National Technology & Security Officer - Microsoft Denmark

The innovative SMART-TRIAL, built on our cloud-technology, enables collaboration with sensitive data across R&D projects and geography. This results in better outcomes for patients and organizations.

All your data safe in one place

SMART-TRIAL is designed to protect your data - by following industry leading standards on security, encryption, and access control.

Read our Security Statement
  • Two-step verification

    Prevent unauthorized access to your account and enable extended validation for critical study actions.

  • Permission-based access control

    Increase security and improve compliance with regulatory requirements with extensive user permission control.

  • Extensive system audit logging

    Track changes and every action on both user and study level.

Comply with international standards

SMART-TRIAL can help you comply with GCP, CFR 21 Part 11, and HIPAA.

Read the GCP, CFR 21 Part 11, and HIPAA Compliance Statement