Security & Quality

Quality assurance using industry leading standards. Developed and design controlled in coherence with IEC 62304 and ISO 13485.

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 »
SOP templates

Streamline the process of documentation and compliance with our SOP templates and validation templates.

Real-time data input validation

Prevent self-inflicted data entry mistakes and eliminate errors using SMART-TRIAL's real-time data input validation.

Change management

Manage and track the changes of data and structure in every study, for compliant data management.

Learn more about the platform

Take a look at the user interface