Ensure Full Compliance with Complete End-to-End Traceability and Auditability

Our platform ensures comprehensive data protection, traceability, and auditability. It adheres to the most rigorous industry standards, including HIPAA, GDPR, and FDA Title 21 CFR Part 11. 



Electronic Signatures

  • Authorized users can access comprehensive audit logs
  • Utilize and examine electronic signatures; approval processes guarantee tracking and authorization
  • Create, view, and answer inquiries during the study

Audit Trails

Comprehensive Audit Trails

  • All data entries and modifications are recorded 
  • Only authorized individuals can make changes to the data, and adjustments to user permissions are tracked and logged


Access Control

  • A security system is in place to prevent unauthorized access to the data
  • Two-factor authentication is used for added security


Backup & Restore

  • Data is saved and can be brought back if needed
  • Support is available for recovery in case of a disaster


Secure Data Storage

  • Data is automatically encrypted when stored
  • Easy storage location for data, with support across various jurisdictions


Periodic Audits

  • Reviewed annually by independent third-party professionals
  • Audited by leading CROs and clinical trial sponsors
Interested to know more?
Download our brochure