SureClinical partners with DigiCert to deliver new high-trust E-signing platform, provide FDA-Compliant Digital Certificate Signing services using web and mobile devices
RANCHO CORDOVA, Calif. October 23 2013– SureClinical™, a leading provider of secure pharmaceutical and healthcare clinical content management solutions, announced today an exclusive partnership with DigiCert®, a global leader in authentication and encryption services, to deliver the first FDA Part 11 and HIPAA compliant Mobile Esignature service in the cloud.
The SureEsign™ service is expected to revolutionize the way pharmaceutical and healthcare organizations handle clinical trial documentation, saving them time and money by eliminating manual paper-signing processes.
Signatures created by DigiCert digital certificates can be used to verify both the source and integrity of a document. Entities using signed documents are assured the document is the original, unmodified version. DigiCert’s inclusion in the Adobe® Approved Trust List facilitates e-signing of Adobe® PDFs and the creation of digital IDs. A digital ID typically contains the signer’s name and e-mail address, the name of the organization that issued the certificate validating the ID, a serial number and an expiration date.
Using these certificates in connection with the SureEsign platform, a signer can execute Adobe PDF documents anytime and anywhere using SureClinical’s new, patent-pending two-factor signing authentication technology. This technology for mobile devices provides strong identification of signing parties and a highly secure environment.
In the pharmaceutical market, the U.S. FDA (under FDA CFR 21 Part 11) requires digital certificate signatures on all documents submitted to its Electronic Submissions Gateway. SureEsign is the first signing service that supports FDA compliant digital certificate signing across organizational boundaries using mobile devices. SureEsign also complies with European Union Country Directives.
“Legacy signing solutions require companies to install and maintain expensive on-site server signing security hardware, signing software, and support services,” said SureClinical President and CEO Zack Schmidt. “These on-site signing services cannot support document signing operations beyond the firewall, limiting the use of digital certificate signing to in-house signing operations. With the new SureEsign platform, FDA clinical trial investigators, clinical research associates, sponsors and research organizations can use a mobile device to electronically sign FDA regulatory documents with their Adobe® Digital ID anytime, anywhere.”
DigiCert’s document signing certificates enable SureClinical to provision highly trusted digital signing services that can be viewed and verified in the latest versions of Adobe® Reader® and Adobe® Acrobat®.
“DigiCert is excited to be the exclusive provider of SureClinical’s document signing certificates,” said DigiCert CEO Nicholas Hales. “DigiCert’s experience with publicly trusted certificates and expertise in security means SureClinical is offering a secure and robust solution that is fully trusted by virtually all browsers and application software suites.”
Documents signed by the SureEsign platform contain a certificate credential that accurately identifies the individual signer. The signature is readily viewed and verified in SureClinical’s mobile, web or desktop clients, or in Adobe Reader or Adobe Acrobat.
The SureEsign platform offers BioPharma and Healthcare organizations the following services:
- Digital signing of office documents or medical images using highly trusted Adobe digital certificates
- Viewing and instant validation of signed documents in Adobe Reader or Adobe Acrobat
- Storage of digital IDs on U.S. NIST approved FIPS-140 level 3 compliant hardware security modules
- Certifications for FDA, HIPAA, PCI, SSAE 16 Type II, and U.S. Safe Harbor/European Commission Privacy Directives
- Integration of digital signing and workflow services with pharmacy and healthcare applications through the SureEsign open API
SureClinical’s SureEsign services are available as an optional module for the SureClinical eTMF cloud application and will be widely available beginning Q4 2013.
Headquartered in Northern California, SureClinical is the premier provider of health science content management software area for BioPharma. SureClinical’s mobile health science content management solutions run on the new Apple® iPad Air™, Apple® IOS, Android ® and other popular smartphone platforms. For more information, visit sureclinical.com.
DigiCert is a premier online trust provider of enterprise security solutions with an emphasis on authentication, PKI and high-assurance digital certificates. Headquartered in Lehi, Utah, DigiCert is trusted by a continually growing clientele of more than 70,000 of the world’s leading government, finance, healthcare, education and Fortune 500® organizations. DigiCert has been recognized with dozens of awards for providing enhanced customer value, premium customer support and market growth leadership. For the latest DigiCert news and updates, visit digicert.com, like DigiCert on Facebook® or follow Twitter® handle @digicert.
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.