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SureClinical Announces SureClinical Certified Cloud™ for North America and Europe
Date:11/28/2013

ealth sciences to offer a secure cloud-based digital signing service that enables investigators to electronically sign documents outside the firewall making the 100% paperless eTMF a physical reality. Our patent-pending signing services support digital certificate signing (PKI x.509). All PKI signing transactions utilize US NIST tested and approved FIPS-140-2 Level 3 technologies.
  • Audit trail: All cloud instances include an exportable, read-only time-stamped audit trail that adheres to FDA requirements for user activity and electronic signing events.
  • Continuous infrastructure monitoring: Proactive infrastructure monitoring, 24x7 throughout our global certified cloud platform to insure uninterrupted service.
  • Security audits: Quarterly PCI system scans and security audits are conducted to ensure security compliance.
  • SureClinical Cloud Certifications

    The technology infrastructure underlying the SureClinical Certified Cloud provides customers with the most comprehensive list of government regulatory validations and certifications in the industry, as well as the infrastructure to support extreme performance, scalability, availability and security needed to run mission-critical, health science specific solutions:

    • SSAE-16 Type I and Type II Attestation: Support for both SSAE-16 Type I and Type II attestations in conjunction with auditor SSAE 16 Solutions.
    • PCI Compliance: Maintenance of a PCI-compliant environment. Certification is optional for customers who purchase the PCI compliance service.
    • HIPAA Business Associate: SureClinical maintains policies and procedures necessary to act as a HIPAA Business Associate for customers whose application maintains data covered by HIPAA regulations.
    • FDA CFR Part 11 Application Certification: SureClinical’s SureTrial eTMF cloud application is independently audited and validated through an ongoing program
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