SureClinical Announces SureClinical Certified Cloud for North America and Europe
First Health Science Application Cloud Platform with Integrated Electronic Signing to offer certifications for US FDA 21 CFR Part 11 and European Commission regulations.
Rancho Cordova, California November 27, 2013
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’s SureClinical eTMF cloud solution is a suite of cloud-based applications delivered on the SureClinical Certified Cloud, purpose-built for clinical trials and validated against US and EU regulatory requirements. 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. “We are very excited to meet our customers’ demands for a highly secure, compliant and validated suite of cloud solutions purpose-built for health sciences. SureClinical’s Certified Cloud with its FDA-compliant SureClinical eTMF cloud application suite will enable BioPharma firms to confidently move mission-critical clinical trial operations business processes to the cloud without compromising security, performance, or reliability, while at the same time maintaining compliance with government regulatory requirements. We are committed to helping BioPharma firms enhance operational efficiency through the cloud,” said Zachariah Schmidt, President and CEO, SureClinical. With the SureClinical Certified Cloud platform and SureClinical’s SureTrial suite of clinical applications, SureClinical provides BioPharma organizations with a secure, agency compliant platform that helps them to realize new operational efficiencies.
SureClinical Certified Cloud Compliance and Security Features
The combination of SureClinical’s Certified Cloud platform and its SureClinical 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. A partial set of cloud compliance and security features are listed below:
- 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.
- 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.
- 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, 24×7 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 SureClinical 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.
Headquartered in Northern California, SureClinical is the premier provider of health science content management software applications for BioPharma. SureClinical’s mobile health science content management solutions run on Android®, Apple® iPad, Apple® IOS, and other popular smartphone platforms, as well as on all major web browsers. For more information, visit SureClinical.com
. Copyright © 2013 SureClinical. All rights reserved. SureClinical, SureEsign, SureTrial, and the SureTrial logo are trademarks of SureClinical. Other names used herein may be trademarks of their respective owners.