SureClinical eTMF Spring 2014 Release Enables 100% Paperless Clinical Trial Operations
Rancho Cordova, California (PRWEB) June 19, 2014 -- SureClinical Inc., an industry-leader in collaborative cloud health sciences applications, announced today the SureClinical eTMF Summer ’14 Release. SureClinical’s latest release includes new integrated high trust digital signing features and integrated clinical trial workflow automation features for automating manual, paper-based processes to help organizations transform into fully digital businesses.
New feature enhancements in the SureClinical Spring 2014 Release include:
-Integrated Mobile High Trust Digital Signing – Now every participant in a clinical trial can effortlessly complete and digitally sign documents anywhere with SureClinical SureEsign, eliminating paper at and providing individual FDA Part 11 and EU compliant signing services to all individuals throughout the clinical trial. SureClinical is the only vendor to offer support for PDF signing with Adobe Digital ID’s from mobile and web devices via the cloud with its patent-pending cloud digital signing service for health science.
-US FDA and EU eSubmission gateway support for digital signing – SureClinical’s digital signing service provides strong verification of signing parties using the same digital signing technology adopted by the US DEA for digital signing of controlled substances by physicians. SureClinical’s patent-pending signing technology uses Adobe Approved Trust List (AATL) certificates for PDF document signing, and offers military grade US NIST approved FIPS-140-2 Level 3 compliance for digital signing in the cloud.
-SureWorkflow™ – As clinical trial operations migrate from paper-based manual processes toward 100% digital operations, SureWorkflow automates clinical trial processes and with real-time cloud-based document workflows across mobile, web and desktops, with integrated digital signing and FDA compliant audit trails to drive cost reductions, increased revenues and enhanced quality for clinical trials, while significantly reducing study-startup time.
-Certified Archive™ - Archiving of documents, medical images and records is simplified with a one-click wizard that creates an Adobe PDF viewable, verifiable Certified Archive of your entire clinical trial content repository, viewable by anyone, anywhere in Adobe Acrobat™. Archives are digitally signed with high-trust Adobe Digital ID AATL certificates, providing long term verification of the signing party, and assuring archive integrity for periods of as long as thirty years, in compliance with EU ETSI PaDES standards.
-Native support for linked data and RDF/XML semantic web 3.0 for accurate document search, classification, and sharing. RDF/XML is the technology used by standards organizations CDISC, OASIS, National Cancer Institute and many other standards organizations for interoperability, giving organizations the ability to integrate with existing applications and taxonomies.
Supporting Quote
“Time is the enemy of the drug development process. Each day of delay bringing a new drug to market costs life sciences companies hundreds of thousands of dollars in uncaptured revenues. Surprisingly, in this highly regulated $200B/yr market, many life science companies manage clinical trials through a combination of manual, paper-based and on-premise electronic systems. This model is time-consuming, costly, inefficient, resource-intensive, and prone to quality issues. SureClinical's patented cloud solution with integrated digital signing and automated workflows provides instant, secure collaboration to dramatically accelerate time to market, eliminating infrastructure costs and delivering immediate value,” said Zachariah Schmidt, President and CEO, SureClinical.
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.
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 21 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.
About SureClinical
Headquartered in Northern California, SureClinical is the premier provider of health science content management software applications for life sciences and healthcare markets. 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, Windows and MacOS. For more information, visit http://www.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.
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Zack Schmidt, SureClinical Inc, 916-265-2000, [email protected]
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