Security & Quality

SMART-TRIAL provides security and quality assurance using industry leading standards. Developed in coherence with ISO/IEC 62304, 13485, and 14971, and the GDPR.

All your data safe in one place

SMART-TRIAL is designed to protect your data. Our strict information security standards prevent your data from being corrupted, mistreated, or manipulated.

Read our Security Statement »
Two-step verificiation

Prevent unauthorized access to your account and enable extended validation for a project sensitive actions.

Permission-based access control

Increase security and improve adherence to regulatory requirements with SMART-TRIAL’s extensive user permission control.

Extensive system audit logging

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


Comply with international regulations and data proficiency standards

Complying with requirements such as GCP, CFR 21 Part 11, and HIPAA can be overwhelming. SMART-TRIAL can help you comply with these by offering various templates and other documents to ease the work.

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

Streamline the process of documentation and compliance with our various SOP templates and other GCP documents.

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

Effectively manage and track the changes, reviews and comments in every project for compliant data management.

Learn more about the platform

Take a look at the user interface