Relsys Releases New Argus 4.1 Web
Relsys International, the leading developer of adverse event reporting and safety profile analysis software for the pharmaceutical industry, announced the release of Argus Safety 4.1 Web, a significant upgrade of its industry-leading adverse event reporting software.
“Ever since its inception, Argus Safety has been designed to meet the specific adverse event reporting needs of leading pharmaceutical companies,” said Dave Bajaj, President and CEO of Relsys. “Working with our customers, we’ve added new features and functions that enable them to more easily stay in compliance with regulatory mandates, and leverage our safety software as an integral component of their risk management strategies.”
Already regarded as the industry’s most complete adverse event reporting solution and used by more of the top ten pharmaceutical companies than any other software product, Argus 4.1 offers a variety of new features, most of which have been requested by and developed in concert with these companies. The new features include:
* Enhanced functionality through modules such as Power Reports, ePSUR, Argus J, Electronic Submission Module, Local Affiliate Module and our PV Module. * Interfaces to Industry leading applications such as Document Management, Global Coding, e-Mail, and FAX. * Sophisticated Security Model that allows sharing (entry, viewing and retrieval) of your Case Safety Data with other companies such as you licensing partners based on products or study of the case. Additional security options allow you to limit what case elements can be accessed. * Enhanced Privacy Protection for Patient and Reporter. * Support for many local expedited reporting forms such as: E2b, CIOMS-I, French clinical and spontaneous, Canadian drug and device, EU Device Vigilance, EU EMEA Clinical and Spontaneous, German, MCA Clinical and Spontaneous, Spanish Clinical and Spontaneous, US Drug, Device and Vaccine. * Flexible PSUR configurations US FDA Waiver support, standard and custom summary tabulations. * Support for EU Clinical Trial Directive including Clinical Trial Periodic Reporting ability. * Powerful MedDRA browser and support tools for upgrading your MedDRA version that will analyze your coded events to assess the impact of the new version and optionally “repair” LLT currency or SOC assignments. * Role Based Views of Case Data such as Initial Intake or Medical Review. * 21CFR Part 11 Compliance including the ability to print case data of any previous revision. * Productivity aids such as: * Personal Workflow * Workflow and Expedited status screens with drill-down capabilities to quickly identify cases that need attention * Sophisticated Support for Device Products including the ability to produce multiple device reports for a single case.
Argus 4.1 is available immediately, and will be demonstrated at the upcoming Argus Safety Users Group meeting in Montreal on September 8-10. For pricing, contact Relsys International at (714) 453-1715.
About Relsys International
Relsys International provides comprehensive adverse event and complaint tracking software and services that help pharmaceutical, biotech and medical device companies ensure ongoing compliance to global regulations. The company, founded in 1987, works in partnership with its customers to develop and deliver innovative solutions to long-term business needs, and to provide critical components to support its clients’ corporate risk management strategies. Argus Safety,(TM) the company’s flagship product, is the world’s best selling adverse event reporting software, and is used by more of the leading pharmaceutical companies than any other solution. Relsys is a privately held company, headquartered in Irvine, California. For more information, visit http://www.relsys.net/ .
