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.
Streamline the process of documentation and compliance with SMART-TRIAL’s SOP templates and validation templates.
We ensure that you can be compliant with the industry latest standard on GCP for Medical Devices.
We deliver ready-to-use SOP templates that you can customise to your own QMS or study protocol.
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.
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
Prevent unauthorized access to your account and enable extended validation for critical study actions.
Increase security and improve compliance with regulatory requirements with extensive user permission control.
Track changes and every action on both user and study level.
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