Certified Cloud for Health Sciences
Validated Global Data Centers
In the highly regulated drug development market, BioPharma organizations must comply with an ever growing list of global government requirements for systems such as FDA 21 CFR Part 11, HIPAA, European Commission Privacy Directives, GDPR and US FDA electronic signing regulations.
To address compliance needs and to accelerate time to value, SureClinical launched SureClinical Certified Cloud™ and SureCompliance to give its life science and healthcare customers immediate access to the operational efficiencies and return on investment offered with its on demand cloud applications, rapid validation service and suite of health science applications.
Compliance and Security Features
Privacy, Security, Scalability & Standards
The combination of SureClinical’s Certified Cloud and its SureClinical application suite provides the premier product, support and services clinical trial organizations need to transition to the cloud, while addressing the demanding and unique security, compliance and operational requirements of the BioPharma sector. SureClinical Certified Cloud supports industry compliance across a broad range of global regulatory requirements, including the USA and EU.
SureClinical Certified Cloud provides you with the infrastructure to support extreme performance, scalability, availability and security needed to run mission-critical, health science specific solutions, including features such as:
- Physical segregation of customer data: SureClinical has optimized its fast virtualized server environment to ensure rapid deployment while meeting the most strenuous requirements of FDA 21 CFR Part 11 for protection of clinical trial data. SureClinical’s physical segregation of customer data approach maximizes the efficiency of cloud infrastructure while delivering the highest levels of cloud data privacy and security.
- Two-factor authentication: SureClinical’s Certified Cloud provides integrated two-factor authentication for electronic signing (pat pending) as well as strong authentication techniques to verify user identification and limit system access per FDA and EU regulations.
- 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 and backups: Proactive infrastructure monitoring, 24×7 throughout our global certified cloud platform to insure uninterrupted service. Daily backups provided.
- Security audits: Quarterly PCI system scans and security audits are conducted to ensure security compliance.
Cut clinical trial operations costs through automated business processes
Gain an immediate return on investment
Save staff time and hassle through outsourced operations
Accelerate clinical product delivery through reduced time to market
Data Center Certifications
FDA Part 11, EC Annex 11, GDPR and more
SureClinical has Certified Cloud data center operations located in over 20 regions globally. The European Certified Cloud data centers meet the privacy standards of the European Commission’s Directive on Data Protection and GDPR.
FDA CFR Part 11 Application Certification: SureClinical cloud applications are independently audited and validated across all global data centers through an ongoing program of continuous QA, validation and certification. These in-depth evaluations of our cloud applications and cloud infrastructure are done against a rigorous set of FDA regulations. Ask for a free copy of our independent FDA Part 11 compliance opinion letter and certification.
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.
SOC 1, SOC 2, SOC 3 Compliance: Support for all major AICPA SOC compliance certifications with independent audit opinion letters continually updated.
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.
EU GDPR Certification: SureClinical is committed to privacy protection. SureClinical’s applications and data centers are fully GDPR compliant. We maintain GDPR compliance through our policies, training and application features that protect privacy under applicable GDPR regulations.
PCI Compliance: Maintenance of a PCI-compliant environment. Certification is optional for customers who purchase the PCI compliance service.
U.S. Commerce Department Safe Harbor Certification: SureClinical’s cloud is certified under the U.S Commerce Department’s Safe Harbor program, which signifies that the SureClinical cloud employs policies and procedures that meet the privacy standards of the European Commission’s Directive on Data Protection. By certifying under the program, SureClinical’s customers can be assured that their personal information is private and protected.
FIPS-140-2 Level 3 compliance: SureClinical’s Certified Cloud is the first cloud solution for health sciences to offer a secure cloud-based digital signing service that enables investigators to electronically sign documents outside the firewall making 100% paperless operations 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.