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
05/01/2027
Worlds first 802.15.4ab-UWB chip verified by Calterah and Rohde & Schwarz to be ...
06/09/2026
June 9 2026, 23:00 (PDT) Dolby and MagentaTV Bring Fans Closer to the FIFA Worl...
04/08/2026
Dalet, a leading technology and service provider for media-rich organizations, t...
04/07/2026
Blackmagic Design Cameras Empower Youth Broadcasting Program
Brie Clayton July 3, 2026
0 Comments
Blackmagic Pocket Cinema Camera 6K Pro and Blackmagi...
04/07/2026
iZotope Joins Boris FX
Boris Yamnitsky July 3, 2026
0 Comments
iZotope, the team behind RX and Ozone, is joining Boris FX. A letter from founder Boris...
04/07/2026
April 7 2026, 19:00 (PDT) Detective Conan: Fallen Angel of the Highway Opens in...
03/07/2026
New bundle & three Single Packs
Continuing to expand their already sizeable orchestral collection, VSL's latest release introduces three new Single Pack...
03/07/2026
Venue installs new ATC-equipped control room
LSO St Luke's, a unique music venue that also serves as the home of the London Symphony Orchestra, have rec...
03/07/2026
Caden Pearson appointed new Commissioning Editor for NITV
3 July, 2026
Media releases
National Indigenous Television (NITV) has strengthened its commitment...
03/07/2026
1 February 2023
SHARE Facebook Twitter Linkedin Email
Munich, Germany, 1st February 2023: Cinegy GmbH, the premier provider of software technology for digit...
03/07/2026
Share
Copy link
Facebook
X
Linkedin
Bluesky
Email...
03/07/2026
Share
Copy link
Facebook
X
Linkedin
Bluesky
Email...
03/07/2026
Share
Copy link
Facebook
X
Linkedin
Bluesky
Email...
03/07/2026
Death Star
Andy Marken July 2, 2026
0 Comments
Look, I can't get involved. I've got work to do. It's not that I like the Empire; I hate i...
03/07/2026
Berklee's New Visual Identity: Honoring Our History, Building for What's...
03/07/2026
Scripps Research scientists awarded $2M to advance global disease surveillance Two Gates Foundation grants will expand wastewater surveillance and AI-driven dis...
03/07/2026
Joan Pulupa joins Scripps Research faculty to study the organization of DNA in brain cells and its links to neurodegeneration Using smell-sensing neurons and ad...
02/07/2026
Entering her senior year, this hometown girl is paving a career in live sports production gaining experience in replay and audio and as a TD
In the live-sports...
02/07/2026
In-venue and creative video staffers at the professional and collegiate level ha...
02/07/2026
BLAST, a competitive entertainment company focused on esports, has announced more than $133 million in revenue for 2025, representing more than 40% year-over-ye...
02/07/2026
Riedel Communications has announced official SKAARHOJ panel support for SimplyLive production workflows, enabled through the SimplyLive 2.1 release. The integra...
02/07/2026
The Fire Rescue Service of the Czech Republic has deployed LiveU video-over-bond...
02/07/2026
Gravity Media USA has announced the appointment of Brittney Boston as Head of Business Development, effective July 1, 2026. Based in Nashville, Tennessee, Bosto...
02/07/2026
TwelveLabs, a video intelligence company, has announced $100 million in Series B funding co-led by NEA and NAVER Ventures, with participation from Amazon, Radic...
02/07/2026
The Pro Padel League (PPL) has announced a broadcast partnership with USA Sports that will air five PPL championship matches on CNBC during the 2026 season, the...
02/07/2026
LiveLike, a digital fan engagement platform, has announced eight confirmed FIFA ...
02/07/2026
Cobalt Digital has received Future's Best of Show Award, presented by AV Technology at InfoComm 2026, for its blueCORE family of standalone signal processor...
02/07/2026
Synamedia has announced the appointment of Dr. Tzvi Gerstl as Chief Executive Officer. Paul Segre, who has served as CEO for the past six years, will transition...
02/07/2026
The Esports Foundation (EF) and Sony Group Corporation have announced an expanded collaboration for the Esports World Cup 2026 (EWC), taking place in Paris, Fra...
02/07/2026
Zee Entertainment Enterprises Ltd. ( Z') has announced exclusive broadcast and digital rights for the Bundesliga in India for five years, beginning with the...
02/07/2026
An effort uniting News, Sports, Local, and Telemundo, the 50+-camera live produc...
02/07/2026
Zoey Deutch, John Slattery, Ken Marino, Miles Gutierrez-Riley, and Ben Wang appe...
02/07/2026
Stammering, stuttering, strangulated tones
The Crow Hill Company's latest creation promises to be the most original sound set they've produced to d...
02/07/2026
A new era in unmixing and spectral editing
The latest version of Steinberg's spectral audio-editing software has just arrived, building on the strength...
02/07/2026
Aims to simplify additive synthesis
Sine Machine is the debut launch from Melatonin, a Vienna-based developer who have spent the past six years creating wha...
02/07/2026
Products to remain fully active & supported
Following the news of Native Instruments joining the inMusic brand line-up, Academy and Emmy Award-winning visua...
02/07/2026
What you missed!
Last weekend, Saturday 27 June 2026, saw the debut of Sound On Sounds new GearExpo UK event, the largest dedicated pro-audio event to take ...
02/07/2026
Share
Copy link
Facebook
X
Linkedin
Bluesky
Email...
02/07/2026
Following the successful launch of its inaugural APAC Mentoring Programme last month, the Rise AV APAC Regional Council will bring the conversation around mento...
02/07/2026
Blackmagic PYXIS 6K Used to Shoot Director Takahisa Zeze's Cry Out
Brie Clayton July 2, 2026
0 Comments
Highly mobile camera supports tense and de...
02/07/2026
Broadcast Solutions acquires BFE, expanding its lead in European broadcast, medi...
02/07/2026
Berklee Alum and Faculty Perform at Boston Public Library's 250th Anniversar...
02/07/2026
Broadcast Solutions GmbH, a leading systems integrator and provider of innovative solutions for the broadcast media industry, is acquiring BFE Studio und Medien...
02/07/2026
Cinegy GmbH, the premier provider of software-defined television technology, has extended the ingest facility at leading Brazilian sports company LiveMode, work...
02/07/2026
Share
Copy link
Facebook
X
Linkedin
Bluesky
Email...
02/07/2026
Standalone processors acknowledged for the innovation and value they bring to Pro AV
Cobalt Digital, a leading designer and manufacturer of signal processing ...
02/07/2026
Synamedia announced today the appointment of Dr Tzvi Gerstl as Chief Executive Officer. Paul Segre, who has served as CEO for the past six years, will transitio...
02/07/2026
Screen Australia backs audience-led filmmaking with new insight-driven initiativ...
02/07/2026
Screen Australia refines guidelines for Narrative Content Development and Docume...
Clinical trials go digital with Thales and SureClinical 
