SureClinical Certified Cloud™ – First Health Science Application Cloud Platform with Integrated Electronic Signing with Certifications for US FDA 21 CFR Part 11 and European Commission
With the continued escalation of drug development costs, BioPharma organizations are increasingly considering cloud computing applications as a means to improve operational efficiencies and to accelerate time to market. In the highly regulated drug development market, health science cloud applications must comply with and be validated against a growing list of global government requirements. US and EU requirements such as FDA 21 CFR Part 11, HIPAA, European Commission Privacy Directives and US FDA electronic signing regulations make it costly, time consuming and difficult for organizations to deploy internally developed applications that adhere to regulatory requirements. To address compliance needs and to accelerate time to value, SureClinical launched SureClinical Certified Cloud™ to give its life science and healthcare customers immediate access to the operational efficiencies and return on investment offered with its SureTrial suite of clinical trial applications.
SureClinical has Certified Cloud data center operations in regional centers throughout North America and in Europe. The European Certified Cloud data centers meet the privacy standards of the European Commission’s Directive on Data Protection.
SureClinical Certified Cloud Compliance and Security Features
The combination of SureClinical’s Certified Cloud and its SureTrial eTMF 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 regulatory requirements n the US 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
SureClinical Certified Cloud provides customers with the most comprehensive list of certifications:
- 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 of continuous validation and certification. These in-depth evaluations of our cloud applications and cloud infrastructure are done against a rigorous set of FDA regulations.
- 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 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.
- Cut clinical trial operations costs through automated business processes
- Provide immediate return on investment
- Save staff time and hassle through outsourced operations
- Accelerate product delivery through reduced time to market
Create, edit and deploy interoperable content classification models
Easily import, edit or create health science content classification models using a simple to use graphical user interface. Supports published health science vocabularies and open Enterprise Content Management systems