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Life Science Organizations Deploy CoSign Standardsbased Digital Signatures...



Following the announcement at the March DIA Conference where a majority of Enterprise Content Management vendors indicated support for CoSign standards-based digital signatures, the market is seeing successful deployments by several life science organizations integrating the CoSign standard digital signature solution with mission critical business applications.



PKI-based digital signatures 's8211; also called electronic signatures - were once an exclusive domain of government and large organization deployments. With the cost effective CoSign solution, however, digital signatures are now being deployed by enterprises of all sizes and across a wide spectrum of applications. CoSign has delivered tremendous value for organizations ranging from clinical sites, central labs, CROs, sponsors and life-science solutions vendors with a Return on Investment (ROI) that is clear and typically measured in just a few months.



There is no doubt the cost-effective manner in which CoSign is deployed has had significant and measurable impact on driving the adoption of digital signature technology, says Rodd Schlerf, Life Science Practice Manager at ARX.



The transformation brought about by CoSign is due to the diversity of applications it supports including the ability to quickly integrate with pre-existing business applications. CoSign allows organizations to realize the inherent promise of digital signatures - that is, more efficient and higher quality approvals and collaboration within internal, business-to-business, and customer-facing processes.



Software vendors, service providers, and life science companies requiring customized applications with digital signatures have found that CoSign's8217;s complete, secure, and centrally managed appliance combined with a simple and intuitive API make rapid integration possible and affordable. Examples include clinical trial systems (CTMS, CDMS, IVRS and EDC), laboratory information management systems (LIMS), electronic medical records systems (EMR), and even non 21 CFR Part 11 regulated applications such as purchasing, HR, and ERP systems. This includes both pre-packaged software applications as well as custom solutions, and a few of these are mentioned below.



Oracle's8217;s Life Science customers are now looking to utilize electronic and digital signatures for user authenticity, business process control for financial transactions, and for ensuring electronic pedigree authenticity. Companies are moving beyond electronic recordkeeping just for compliance, and are understanding the business benefits of improved collaboration, reduced risk and the enforcement of best practices that digital signature technology enables said John Danese, Life Sciences ERP Product Director at Oracle.



One of the most popular enabling technologies today is Microsoft Office SharePoint Server (MOSS). CoSign's8217;s ability to cost-effectively deploy a standards-based digital signature, combined with MOSS's8217;s Web interface, enables multiple architectures to serve dispersed and mobile collaborating in life sciences organizations, says Paul Mattes, US Life Sciences Industry Solutions Director for Microsoft.



Microsoft partners providing business solutions, in industries such as life sciences and healthcare, have developed and deployed integrated solutions with CoSign. The integrated product offering enables life-science organizations operating in regulated environments to manage processes and compliance with a unified solution while reducing the cost and complexity of compliance, said Zikria Syed, CEO of Microsoft Gold Partner, NextDocs. Using CoSign's8217;s COM object or Web-Service API has enabled us to quickly build out digital signature solutions for MOSS 2007 for regulated applications for a variety of biopharmaceutical companies, contract service organizations, and healthcare providers.



CoSign is also integrated with many clinical information and management systems to eliminate the huge paper and priority mail costs associated with time critical applications such as CRAs signing Monitor Trip Reports and investigators signing all of the documents constituting the Regulatory Packet. For example, CoSign is integrated with the Datalabs Site Manager CTMS application which is deployed in a Top 10 CRO with over 5,000 users, including thousands of investigator sites. With CoSign, the sites, IRBs and sponsors can all sign the various documents, which include the protocols, consent forms, 1572s, CVs and other agreements and forms, required to initiate a study for specific clinical investigator sites conducting a study.



IBM'ss customers are expressing interest in deploying standard digital signatures, and IBM sees the technology as complementary and good value add to its life-sciences solutions and services, said Grace Tseng, IBM Director of Life Sciences and Healthcare Business Development. Our customers want to simplify and improve processes, reduce paper usage, and ensure compliance. Digital-signature technology by design enables these demands to be addressed, and the ARX CoSign system is among the best approaches we have seen for delivering these capabilities in the application environment while protecting the customer'ss current IT investment.



Custom business applications can also be integrated with CoSign. Steve Trigilio, Chief Technology Officer of Beardsworth Consulting (CRO) integrated CoSign with the company's8217;s internal Clinical Trial and Data Management system, Our programmers were able to focus their time on the end-user experience because they could rely on the CoSign appliance and the ARX technical staff to handle the complexities of the underlying signing process. We were able to reduce the complexity and cost of the solution.



Maxxam Analytics 's8211; the largest private central lab network in Canada 's8211; has integrated CoSign with their internally developed LIMS system. CoSign works seamlessly with the PDF-based reports created in our workflow, said Maxxam's8217;s Application-Development Manager, Sorin Bobariu. Maxxam signs and seals around 15,000 reports every month and each of Maxxam's8217;s 14 labs process an average of over 100,000 samples every year that can be electronically signed and then downloaded by clients without any paper documents.



GlobalVetLink (GVL) has successfully integrated CoSign into their custom veterinary web portal to allow hundreds of DVMs to sign OCVI and EIA forms. GVL operates in a regulated environment and is subject to compliance with numerous US government regulations governed by the FDA and USDA. CoSign ensures we stay in compliance while helping improve efficiency in all aspects of animal health and movement records, said Kevin Maher, President of GlobalVetLink.



In the healthcare market, many organizations have integrated CoSign with Electronic Medical Record systems in order to make them compliant with HIPAA Security Standards as well as achieve the portability of EMR that is generally missing in proprietary systems. The entire state of South Carolina Department of Mental Health is deploying CoSign integrated with an internally developed web based EMR being deployed for all 21 statewide hospitals and clinics, including over 3,500 medical staff, and tens of thousands of patients.



About CoSign®

CoSign by ARX is a highly scalable, standards-based electronic signature (digital signature) solution. Signing and sealing electronic documents with CoSign will immediately expedite business processes, reduce costs, increase security and help organizations comply with regulations. CoSign electronic signatures are based on standard PKI technology, guaranteeing signer authenticity, data integrity and the non-repudiation of electronic documents.



CoSign is cost-effective highly secure (FIPS validated), and has a high-availability fault-tolerant configuration. The solution is also versatile having been deployed in a range of industries, life sciences, healthcare, financial commercial, and government.



CoSign supports all major applications and file formats (MS Word, Excel®, Outlook®, PDF, IBM Workplace Forms, TIFF, AutoCAD, InfoPath and many more). With a rapid deployment, unique centralized approach, built-in integration with an organization'ss existing user-management directory systems, and extensive 3rd party application support, CoSign guarantees a quick ROI. For more information please visit www.arx.com/products/cosign.php



About ARX Inc. (Algorithmic Research)

ARX (Algorithmic Research) has 20 years of experience assisting life sciences, healthcare, financial institutions, governmental organizations and commercial sectors to secure and streamline their processes and transactions. The company is a leading global provider of standards-based electronic signature and data-security solutions. ARX offers a wide range of high-end and state-of-the-art products and services designed to simplify, secure, and accelerate electronic transactions. In the life sciences industry, clients include biopharmaceutical and medical device organizations, contract research organizations, central labs, clinical sites and hospitals, and various software and service providers. For more information, please visit www.arx.com



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






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