Clinical Trials Go Digital with SureClinical and Thales

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Pharmaceutical and medical device companies bring new drugs and therapies to market faster and more cost-efficiently through a secure, cloud-based regulatory document solution

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"SureClinical’s high trust cloud applications network and digital signing technology accelerates time to market for new drug therapies and medical devices," -Zack Schmidt, CEO SureClinical

Thales, a world leader in critical information systems and cybersecurity, and SureClinical, a global provider of cloud-based content management application software and services for health sciences, announce that Thales nShield hardware security modules (HSMs) are being used by SureClinical, to secure its cloud-based digital signing solution. Pharmaceutical and healthcare companies can now conduct clinical trials faster and more cost-efficiently, accelerating speed to market, without compromising security.

SureClinical allows pharmaceutical companies to eliminate paper, share documents easily, automate document handling, and capture regulatory-compliant signatures on hand-held devices – the tablets and smart phones that most clinicians prefer. However companies developing new drugs are subject to the strictest standards of security and privacy, and are audited regularly.

Thales HSMs are used to secure the built-in Adobe document signing/verification technology and provide a strong anchor of trust in the digital signature process. It is the first cloud-based digital signing solution to win US Food and Drug Administration (FDA) and European commission compliance validation for use in pharmaceutical trials.

Supporting Quotes
“Modernization of clinical trials is a key initiative for both the pharma industry and global regulatory agencies. In an industry with a 20-year patent cliff – SureClinical’s high trust cloud applications network and digital signing technology accelerates speed to market and saves companies hundreds of thousands of dollars in shipping costs, maximizing return on investment for new drug therapy investments," said Zachariah Schmidt, President and CEO of SureClinical. "The adoption of this technology would be out of the question if it didn’t meet the trust and security requirements mandated by regulatory agencies and the industry. Thales was the only company that was able to provide the assurance and strong cryptographic technology that met both the needs of the pharmaceutical companies as well as the regulatory standards of the FDA and the European Commission. Thales helped us deliver a solution that the pharmaceutical companies would trust.”

“We are proud that SureClinical selected Thales nShield HSM to secure their digital signing services," said Cindy Provin, President Thales e-Security Inc. "This allows clinicians, wherever they are in the world, to use mobile applications to securely sign documents at the point of origin, speeding the process and providing greater efficiencies. This secure service is leading the market for the acceleration of safe delivery of new drug therapies through the elimination of manual paper-based processes while still meeting the regulations associated with FDA and EU signing services.”    

To securely authenticate users and share documents that include patient information and intellectual property, the SureClinical solution utilizes Adobe AATL X.509 compliant certificates protected by FIPS 140-2 level 3 Thales nShield Connect HSMs. The certificates can be independently verified by any third party recipient, with an audit trail available for all signing transactions. Based on digital certificate technology secured by a Thales nShield Connect HSM, the solution requires signers to have the right mobile phone, the right PIN, and the right username and password before they are allowed to digitally sign a document with their HSM-protected private signing key – significantly reducing the possibility of fraud. The HSMs reside in data centers that are audited to FDA 21 CFR Part 11, European Commission Annex 11, and HIPAA standards.

Supporting Resources
Download the free white paper on SureClinical's digital signing solution for health sciences at: http://www.sureclinical.com/publicationdownloads/

About SureClinical
SureClinical provides cloud-based health science applications that automate business processes and eliminate paper. SureClinical’s Collaborative Cloud includes integrated document completion, eSigning and archiving for networks of health science organizations that wish to share documents in an automated, regulated cloud environment. SureClinical's applications run on Android®, Apple® iPad, Apple® IOS, and other popular smartphone platforms, as well as on all major web browsers. For more information, visit http://www.SureClinical.com. Copyright © 2015 SureClinical. All rights reserved. SureClinical, SureEsign, SureClinical eTMF, Certified Cloud, SurePortal and the SureTrial logo are trademarks of SureClinical. Other names used herein may be trademarks of their respective owners.

About Thales
Thales is a global technology leader for the Aerospace & Transportation and the Defence & Security markets. In 2013, the company generated revenues of €14.2 billion ($18.3 billion) with 65,000 employees in 56 countries. With its 25,000 engineers and researchers, Thales has a unique capability to design, develop and deploy equipment, systems and services that meet the most complex security requirements. Thales has an exceptional international footprint, with operations around the world working with customers and local partners. http://www.thalesgroup.com

Positioned as a value-added systems integrator, equipment supplier and service provider, Thales is one of Europe’s leading players in the security market. The Group’s security teams work with government agencies, local authorities and enterprise customers to develop and deploy integrated, resilient solutions to protect citizens, sensitive data and critical infrastructure.

Drawing on its strong cryptographic capabilities, Thales is one of the world leaders in cybersecurity products and solutions for critical state and military infrastructures, satellite networks and industrial and financial companies. With a presence throughout the entire security chain, Thales offers a comprehensive range of services and solutions ranging from security consulting, intrusion detection and architecture design to system certification, development and through-life management of products and services, and security supervision with Security Operation Centres in France and the United Kingdom.

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Zack Schmidt

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