Clinical trials go digital with Thales and SureClinical

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

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.

Zack Schmidt, President at SureClinical says:

“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 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. 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.”

Cindy Provin, President Thales eSecurity Inc. says:

“We are proud that SureClinical selected Thales nShield HSM to secure their digital signing services. 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.

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