Clinical trials go digital with Thales and SureClinical
Clinical trials go digital with Thales and SureClinical
February 17, 2015
Pharmaceutical companies bring new drugs to market faster and more cost-efficiently through a secure, cloud-based regulatory document solution
Plantation, Fla. - February 17, 2015 - 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.
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 e-Security 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.
Supporting resources:
Solution brief: www.thales-esecurity.com/knowledge-base/case-studies/sureclinical
For industry insight and view on the latest key management trends check out our blog at www.thales-esecurity.com/blog
Follow Thales e-Security on Twitter @Thalesesecurity, LinkedIn, Facebook and YouTube
About Thales e-Security
Thales e-Security is a leading global provider of trusted cryptographic solutions with a 40-year track record of protecting the world's most sensitive applications and information. Thales solutions enhance privacy, trusted identities, and secure payments with certified, high performance encryption and digital signature technology for customers in a wide range markets including financial services, high technology, manufacturing, and government. Thales e-Security has a worldwide support capability, with regional headquarters in the United States, United Kingdom, and Hong Kong. www.thales-esecurity.com
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. 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 s
Most recent headlines
06/10/2025
France T l visions, France's leading broadcaster, has received the 2025 EBU ...
04/09/2025
Monumental Sports & Entertainment (MSE), in collaboration with Dalet, has been a...
31/08/2025
Legrand | AV, a global specialist and industry leader in audiovisual solutions, returns to CEDIA Expo 2025, taking place Sept. 4-6 in Denver, with a powerful li...
31/08/2025
Global media technology company Backlight will unveil new capabilities in its Iconik, Wildmoka, and Zype product lines at IBC2025 (booth #1.D09), September 12 1...
30/08/2025
WASHINGTON The Federal Communications Commission has adopted its FY 2025 Regulatory Fees Order that establishes the regulatory fee rates for the broadcast stati...
29/08/2025
Australian Red Cross and SBS launch training to help workplaces in the fight aga...
29/08/2025
The National Film and Video Foundation (NFVF), an agency of the Department of Sp...
29/08/2025
L3Harris Technologies has concentrated decades of expertise across the entire enterprise to develop affordable and reliable best-of-breed solutions to rapidly c...
29/08/2025
BURBANK, Calif. The CW Network and the Pac-12 Conference have announced a new media rights deal that will extend their broadcast partnership beginning with the ...
29/08/2025
NEW YORK Gracenote has released a new analysis of its global video dataset showing that the number of FAST channels grew nearly 14% from Q1 2025 and 76% since 2...
29/08/2025
SAN JOSE, Calif. Harmonic has announced a series of improvements to its live sports streaming solution that the company said will improve fan engagement, protec...
29/08/2025
NEW YORK and LOS ANGELES Fox Corp. and YouTube TV last night announced a renewal of the full portfolio of Fox networks, including Fox News Channel, Fox Business...
29/08/2025
Budapest, Hungary, August 2025 - The integration of Microsoft Teams Rooms (MTR) with Lightware's Taurus universal matrix switchers delivers a new level of f...
29/08/2025
Frequency, the engine behind many of the world's best-known streaming television channels, today announced it will launch Studio Live, a next-generation uni...
29/08/2025
In an era when AI and cyber resilience are essential, Scality will mark the 10th anniversary of Scality Day on October 16, 2025 in Paris. This flagship global e...
29/08/2025
Disguise's In-House Creative and Technical Teams Pre-Visualised, Programmed and Delivered Content for the Experience, All Powered by EX 3+
Technology solu...
29/08/2025
Disguise will be demonstrating the latest workflows for TV, film and live events on a number of partner booths at the show
Disguise, the industry-leading tech...
29/08/2025
STOCKHOLM, Sweden Accedo will showcase Accedo Compose, its AI agent-powered modular orchestration layer that assists streaming providers in transitioning client...
29/08/2025
LOS ANGELES Cineverse has announced that it is working with Xperi to bring four of its streaming channels to automobiles for the first time as part of the DTS A...
29/08/2025
DALLAS & ATLANTA Gray Media has announced an agreement with the sports streaming service Victory+ to simulcast 17 Dallas Stars NHL games in 15 television market...
29/08/2025
NEW YORK AND CULVER CITY Comcast NBCUniversal and Amazon have announced new and extended distribution agreements that will expand the content available on their...
29/08/2025
FOOTHILL RANCH, Calif. RED Digital Cinema will feature its Cine-Broadcast Module supporting live broadcast workflows during IBC2025, Sept. 12-15, at the RAI Ams...
29/08/2025
29 Aug 2025
Kyivstar Rings Opening Bell at Nasdaq Marking Landmark Listing and ...
29/08/2025
More than half of all NFL games live on Sky for the first timeFriday 29 August 2025
Sky Sports has announced a new three-year deal with the NFL, extending its ...
29/08/2025
Back to All News
RIV4LRIES: The Trailer of the New Series With Samuele Carrino ...
29/08/2025
Get ready for an inspiring and emotional insight into the world of competitive Irish dancing with My Story: Tomi Champion of the World airing on RT 2 this monda...
29/08/2025
RT has today announced that David McCullagh is to be the new presenter of RT Radio 1's flagship Today programme, which airs every weekday at 10am, replaci...
28/08/2025
By Kristin Feeley, Director, Documentary Film & Artist Programs
If you want to tell untold stories, if you want to give voice to the voiceless, you've got ...
28/08/2025
Directed by Steven Bognar and Julia Reichert, Sundance Institute-supported Amer...
28/08/2025
Corridos have been a cornerstone of M sica Mexicana for generations, telling stories rooted in everyday life. Now, a new chapter is taking shape: motivational c...
28/08/2025
Los corridos han sido un pilar de la M sica Mexicana durante generaciones, contando historias enraizadas en la vida cotidiana. Ahora, un nuevo cap tulo est tom...
28/08/2025
Earlier this month, we promised our Verano Forever party would bring the heat, a...
28/08/2025
L3Harris will provide the Polish F-16V fleet with the Viper Shield electronic warfare system as part of an upgrade program....
28/08/2025
Bilbao, August 26, 2025 - AgileTV, an international television and video technol...
28/08/2025
Ken Wilkinson is an Emmy Awards nominated New York audio engineer who specialises in production sound mixing for film, commercial, episodic and documentary work...
28/08/2025
NEW YORK FuboTV today announced that it will launch Fubo Sports, a skinny bundle that focuses on sports with a subscription price of $56 monthly....
28/08/2025
NEVADA City, Calif. At IBC2025, Sept. 12-15 at the RAI Amsterdam, Telestream will debut its new Global Ingest strategy, introducing a next-generation ingest arc...
28/08/2025
Dr. Rhoda Bernard Releases Groundbreaking Debut Book on Accessible Arts Educatio...
28/08/2025
TAG Video Systems, the leader in software-based IP end-to-end workflow monitoring, deep probing, and real-time visualization, has named Oliver Gappa as Sales Di...
28/08/2025
AI-based voice enhancement will be among a series of innovations making their IBC 2025 debut on the DHD stand B46 in Hall 8 at the RAI Amsterdam Convention Cent...
28/08/2025
Telef nica Servicios Audiovisuales (TSA), the leading system integrator and service provider in the media sector in Spain, with the support of Appear, the globa...
28/08/2025
To fully immerse sailing fans in the world's biggest offshore yacht race, production company, Optical Media turned to LiveU's On-site Production solutio...
28/08/2025
Working with Calrec on its most recent overhaul, radio and television broadcaster, WNED has migrated to a fully IP infrastructure with multiple Type R consoles,...
28/08/2025
Cleeng, the Subscriber Retention Management (SRM ) inventor, has unveiled Cleeng Pro, the first-ever direct-to-consumer (D2C) subscription management platform t...
28/08/2025
Zixi, the industry leader in live broadcast-quality video over IP, today announced that French media distribution platform OKAST has selected Zixi to enable rel...
28/08/2025
Solution offers a streamlined, speaker-free architecture to optimize integration with premium external loudspeakers and advanced loudness metering
Nixer Pro Au...
28/08/2025
Cinegy, the premier provider of software-defined television technology, has announced a strategic partnership with Vision One Touch Film Production Services L.L...
28/08/2025
Telestream, a global leader in media workflow technologies, will debut its new Global Ingest strategy at IBC2025, introducing a next-generation ingest architect...
28/08/2025
Tier 1 operator selects Broadpeak to power high-performance, unified CDN solution across Norway, Sweden and Finland
Broadpeak, a leader in streaming and moneti...
Clinical trials go digital with Thales and SureClinical 
