Data Safety and Security

Medrio is Committed to Keeping Your Data Safe and Secure

The Safety and Security of Your Data Begin with Our Dedication to Compliance

In situations where patient privacy is at stake and where the fate of new life-saving therapies depends upon data security, Medrio’s strict adherence to global compliance guidelines provides certainty and confidence.

We make sure our platforms and systems maintain compliance with regulations in the diverse countries and regions where our clients operate. Our internal compliance and security teams work closely with independent auditors to stay on top of changing regulations and to ensure that everything we do reflects evolving guidance for privacy and security.

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  • Validated Environment
  • Audit Trail
  • Access Level Restricted by Role
  • Incremental and Daily Full Backups
  • Encryption at rest and in transit
  • Two-Factor Authentication (2FA)
  • Electronic Signatures
  • Session Time-Outs
  • Single Sign-On (SSO)
  • Password Expiration
  • User Lock-Out
  • Operations Monitoring
  • Disaster Recovery
  • Business Continuity Plan
  • Quality Management System/SOPs

Data Security

Protecting our clients’ data security is critical to all we do. That’s why Medrio’s compliance team regularly audits our systems and processes to ensure continued strict adherence to our own high privacy and security standards and industry-leading standards as well.

Compliance Standards

  • ICH Good Clinical Practice (GCP)
  • FDA 21 CFR Part 11 Compliance
  • Annex 11
  • General Data Protection Regulation (GDPR)
  • HIPAA & HITECH
  • CDASH & CDISC
  • ISO 9001 Quality System
  • ISO 27001
  • SOC 2

Data Privacy

All Medrio software and platform features are built to ensure regulatory compliance from the ground up, so our clients have the comfort of knowing their trial data – including identifiable patient data – will remain private and protected. From GDPR to HIPAA & HITECH, Medrio’s compliance team is constantly monitoring changing laws and standards to ensure our technologies continue to provide the highest level of privacy possible.

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