CoSign® Electronic Signatures delivered with DataLabs Site Manager™ 2.0

Algorithmic Research (ARX), a leading worldwide provider of electronic signatures and data security solutions, announced from the Drug Information Association (DIA) 42nd Annual Conference an agreement to integrate its CoSign electronic signature solution with DataLabs’ Site Manager 2.0 collaboration software.

This integrated solution enables sponsors and CROS to electronically sign documents, forms and agreements using standard electronic signatures, which reduces the time and cost to clinical trials while complying with the FDA's 21 CFR Part 11 and GxP regulations.

"CoSign’s integration with Site Manager 2.0 allows clinical trial sponsors and CROs to electronically complete, approve, sign and manage the documents that constitute the Regulatory Document Packet required from investigators," says Zikria Syed, VP Product Management, Collaboration Solutions, DataLabs. "Participants are able to electronically sign and submit these documents in real-time without having to generate a hard copy as the source document."

Site Manager users can utilize CoSign to complete regulatory document packets and to electronically sign and approve clinical trial documents including master protocols and informed consent forms. Monitors and clinical research associates (CRAs) can sign trip reports and spreadsheets, investigators can sign grant payment requests and project managers can sign a wealth of trial-related documents including data management reports and documents, financial reports, spreadsheets, and study supply reports and requests. Enhanced electronic collaboration results, increasing the efficiency and accuracy of data capture.

“CoSign’s electronic signature solution integrates seamlessly with Microsoft®’s Active Directory allowing customers in the biopharmaceutical market to move from paper-based to electronic business processes without additional system administration,” says Steve Shihadeh, General Manager, Healthcare and Life Sciences at Microsoft. “Their use of Microsoft technology enables increased user acceptance and improved efficiency, helping people to better connect and collaborate as well as make more informed business decisions.”

CoSign enhances Microsoft support for electronic signatures through its development of graphical signatures, multiple signatures and sectional signing, benefiting customers challenged with multiple approval processes and 21 CFR Part 11 compliance. With Microsoft’s built-in Certificate Authority, CoSign eliminates the PKI management burden.

"Sponsors and CROs stand to benefit from the integrated solution," says Rodd Schlerf, Life Sciences Practice Manager, ARX. "This solution reduces the time for site initiation, and drives greater control and reduced costs associated with regulatory compliance and record retention of ongoing trial activities."

Using industry standard electronic signatures, signed documents can be verified and validated without any proprietary technology required or legacy system that requires maintenance. "CoSign ensures a signed document can stand on its own as electronic evidence of the signer’s identity and intent, and protects the integrity of a documents content today or decades into the future," says Schlerf.

ARX is an exhibitor at the DIA Annual Meeting on June 18-21, 2006, at the Pennsylvania Convention Center in Philadelphia, and will host product demonstrations at booth 1118. Schlerf will speak about electronic signatures in the pharmaceutical industry in a panel discussion Wednesday June 21, 8:30 a.m.

DataLabs is an innovative developer of Web-based applications for clinical development that helps the CRO and biopharmaceutical industries accelerate clinical trials with proven software for electronic clinical data management, electronic clinical collaboration, site management, and web based eLearning software. Based on Microsoft platform
technology, XML Web services and CDISC ODM standards, the DataLabs Clinical product suite adapts to established
operating procedures and integrates easily with existing technology systems. As a result, DataLabs Clinical customers enjoy
a low total cost of ownership and high return on investment. Major pharmaceutical companies, government entities, healthcare organizations and contract research organizations (CROs) are currently realizing time and cost savings using DataLabs eClinical Data Management, eCollaboration, and eLearning platforms. DataLabs, a Microsoft Gold Certified Partner, is based in Irvine, Calif. with East Coast offices in Pennsylvania. For more information, visit www.datalabs.com

About CoSign®

CoSign® is an electronic signature solution based on standard PKI technology. CoSign guarantees signer authenticity, data integrity, and non-repudiation of electronic documents. With CoSign’s standard electronic signatures organizations can sign and seal electronic documents, expedite business processes, reduce costs, increase security and comply with regulations.
The CoSign electronic signature solution supports all major applications and file formats (Word, Excel, Outlook, PDF, TIFF, AutoCAD, InfoPath and many more). With a rapid deployment, unique centralized approach, built-in integration with an organization's existing user-management directory systems, and extensive third-party application support, CoSign drives a quick ROI.
CoSign® is a registered trademark of Algorithmic Research, Ltd. All other trade names and trademarks are the property of their respective holders.
Additional information about CoSign is available at www.arx.com/products/cosign-digital-signatures.php.

About Algorithmic Research (ARX)

Algorithmic Research (ARX) is a leading global provider of electronic-signature and data-security solutions. The company offers a wide range of high-end and state-of-the-art products and services designed to simplify, secure, and accelerate electronic transactions. ARX specializes in designing and implementing easy to use, simple to deploy, electronic signature and security solutions, combining software and hardware products, for small, medium and large computing environments.

ARX has more than 18 years of experience in assisting financial institutions, governmental organizations and commercial sectors to secure and streamline their processes and transactions. In the life sciences market, ARX clients include biopharmaceutical, medical device, and nutritional companies, contract research organizations (CROs), hospitals and clinics, central laboratories, and contract service organizations and software vendors proving clinical trial focused solutions, electronic medical records systems, and imaging systems. CoSign is deployed in applications regulated by FDA 21 CFR Part 11 for Electronic Records and Signatures. ARX is a member of the SAFE BioPharma partner program www.safe-biopharma.org. Additional information about ARX Life Science practice is available at www.arx.com/industries/lifesciences.php.