Simplifying MedTech Regulatory Compliance

Designed and developed in compliance with the PIC/S Guidance, PI-011-3 Good Practices for Computerized Systems in Regulated “GxP” Environments, with software validation based on IEC 62304.

MDR Compliance with 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 & Service Level 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 simplifies regulatory compliance for ISO 14155 (GCP), FDA 21 CFR Part 11, GDPR, and HIPAA by offering ready-to-use QA templates, system modules, and guidance documents.

Read the GCP, FDA Part 11, and HIPAA Compliance Statement