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Press Releases

AxxiTRIALS Portal and CoSign Digital Signatures Enable Accelerated Site and Study Initiations

Litera, vanguard in risk and productivity management solutions, and ARX Inc., the global leader in digital signature solutions, are pleased to announce that the Litera AxxiTRIALS clinical trial site portal is now powered by version 6 of the CoSign digital signature system. The new features in this latest release of ARX further the AxxiTRIALS powerful and 21 CFR Part 11 compliant Esignature functionality.

Litera AxxiTRIALS, a secure portal solution that speeds trial operations processes from Feasibility to Close-Out, helps complete studies on time, on budget and with the quality of data required. In the AxxiTRIALS portal, trial teams (including sponsors, CROs, investigators and IRBs) work together on clinical trials collaborating on documents while avoiding the delays and costs typically associated with paper-based studies.

The CoSign digital signature engine enables AxxiTRIALS to completely eliminate the need to reintroduce paper each time a signature is required, and also eliminates courier fees and other paper-related costs. Now, with the latest release from ARX, users can expedite their site and study initiation and continue site activities at lower costs, while gaining significant cost savings considering the range of documents that require signatures and the number of sites that can be involved in a single study.

Susan Lewenz, Vice President and General Manager at Litéra AxxiTRIALS, notes: “We are big believers in reducing paper in the trials and CoSign has been a huge part of this. This new release furthers the power under the AxxiTRIALS “hood”. Our AxxiTRIALS clients are now able to collect 85% of the signatures they need in a period of 24-48 hours.”

“CoSign is a key tool for Pharma companies seeking to accelerate processes,” says Rodd Schlerf, FDA Markets Manager at ARX. “AxxiTRIALS is a great example of how collaborative cloud services can also benefit from integrating CoSign into their systems in order to provide their users with the ability to securely and compliantly sign documents.”

About Litera

Litera offers a comprehensive content risk management suite of cyber-secure document creation, collaboration, and control technology that provides organizations with unsurpassed Content Confidence®. Litera’s patented solutions increase productivity throughout the document lifecycle, and enable more secure and effective collaboration between people, teams and organizations to empower ideas that drive success. Litera solutions offer information workers and mobile professionals the ability to manage their documents and data with a degree of control not available through any other applications on the market. Learn more at www.litera.com.

About CoSign by ARX

CoSign by ARX is the most widely used digital signature solution in the life sciences market, employed by over 20,000 FDA-regulated organizations including 9 of the top 10 Pharmas and 7 of the top 10 CROs. It is the only digital signature system that supports compliance with strict industry requirements including the FDA’s 21 CFR part 11 and GxP audits. CoSign was recognized as “the strongest digital signature solution” in the Forrester Wave: E-Signatures 2013 report.

By seamlessly integrating digital signatures into their workflows, applications and services, our life sciences customers transformed their slow and expensive signature-dependent processes into quick and efficient paper-free ones. They rapidly reach ROI through reductions in process times and paper-related costs, while ensuring trust, integrity, control and compliance across their business and IT environments.

Visit our web site to learn more about how your Life Sciences organization can benefit from the CoSign digital signature solution.

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CoSign is a registered trademark of Algorithmic Research, Ltd. Litera® is a registered trademark of Litera Corp. All other trade names and trademarks are the property of their respective holders.

Press release orginally published by CoSign by Arx, Inc.

Litera Expands Collaboration Suite with Acquisition of AxxiTRIALS Clinical Trials Portal

Enables secure global document sharing and community management tools for life sciences

McLeansville, N.C. – August 15, 2013 – Litera® announces the acquisition of AxxiTRIALS, a leading Clinical Trials Portal solution providing life science companies and clinical research organizations (CROs) with a platform designed to dramatically speed site start-up, patient recruitment, and end-to-end clinical trial operations.

"This acquisition is in keeping with Litera's continued strategic focus on secure, compliant collaboration and nicely aligns with our content management product portfolio," said Litera President Karen Massand. "We see AxxiTRIALS, with its emphasis on outstanding user interface, community building and engagement tools, together with Litera's powerful document lifecycle, security and collaboration solutions as an absolutely unbeatable combination."

AxxiTRIALS improves operating efficiencies by uniting global trial teams, from Sponsor, CRO and sites, under a single interface that is easy to use, engaging and integrated with existing systems. AxxiTRIALS' customizable workflow tools and compliant document management system speeds the site start-up process, ensures compliance, centralizes key trial information, creates community and keeps investigators and site coordinators engaged throughout the clinical trial.

"Pharmaceutical, medical device, biotech and clinical research organizations that leverage the power of the web see a tremendous acceleration of their trials, particularly in the areas of start-up and patient recruitment, enabling life-saving products to get to market faster," said Susan MH Lewenz, founder of AxxiTRIALS and now VP and General Manager at Litera for the AxxiTRIALS franchise. “Interestingly, the CRO clients who have private-labeled our offering tell us that it has even helped them win new business, as many trial sponsors have now witnessed this speed improvement and demand a portal be used for their projects.”

AxxiTRIALS is used for trials of all sizes in locations all around the world to accelerate document handling from feasibility and site start-up documentation, to ongoing safety alert, training and communications management, through the locking of the trial master file. Like other Litera products, AxxiTRIALS is designed to be so intuitive that it requires little or no training, works on any device anywhere in the world and provides the right content and tools for the business process.

AxxiTRIALS joins a powerful suite offered by Litera, including its Galaxy portal solution for document and matter collaboration across enterprises, as well as solutions for document templates and numbering, content assembly, document comparison, rights management, large/secure file transfer and synchronization, and metadata management.

About Litera

Litera offers a comprehensive suite of cyber-secure document creation, collaboration, comparison, control and cleaning technology that provides organizations with unsurpassed content confidence; information workers and mobile professionals can manage their documents and data with a degree of control not available through any other applications on the market. Litera’s patented solutions enable more secure and effective collaboration between people, teams and organizations to empower ideas that drive success. Visit www.Litera.com now.

Events:

CLINICAL STUDY TEAMWORK

Building Effective Partnerships
Embassy Suites
Raleigh-Durham/RTP, NC
April 10-11 2014

DIA 2014 50th Annual Meeting

Celebrate the Past - Invent the Future
San Diego Convention Center
San Diego, CA
June 15-19, 2014

Disruptive Innovations

Disruptive Innovations to Advance Clinical Trials
The Fairmont Copley Plaza
Boston, MA
September 11-12, 2014