Solution Automates IBC Protocol Operations and Addresses Medical Research Compliance Requirements
AUSTIN, Texas, June 10 /PRNewswire/ -- TOPAZ Technologies, a leading provider of medical research management software for the Life Sciences industry, today announced the latest software addition to its product line, the Biosafety Solution.
TOPAZ Technologies Biosafety Solution automates the medical research study protocol process, from protocol inception to approval, as required by the Institutional Biosafety Committee (IBC). An end-to-end solution for the IBC protocol process, the Biosafety Solution compiles, tracks and manages complex research study data and creates an audit trail with comprehensive reports to prevent and protect against regulatory compliance violations.
Composed of three unique modules, the solution is designed to address key milestones and compliance requirements. Modules include: the Protocols Module, created to streamline IBC protocol development and store critical research information; the Reviews Module, developed to compile and track activities throughout the IBC protocol review process; and the Meetings Module, designed to schedule and capture IBC meeting activities.
"Our experiences with TOPAZ Technologies automated protocol solutions have given us confidence that we will achieve our overall goals to increase efficiency, and efficacy of our compliance programs, ensuring compliance adherence by the TSU research community," said Linda Gardiner, Ph.D., director of the Department of Research Enhancement and Compliance Services Office of Research at
Key features include: customizable biosafety protocol forms; automated protocol monitoring, tracking and management; regulatory reports and audit trail; collaborative review environment; user-defined role and protocol-based access control; meeting agenda scheduler; and user-defined templates for recording meeting minutes.
"With recent market changes, international consolidation and increasing complexity in the regulatory and compliance process, TOPAZ Technologies recognized a growing need for a more effective way to manage the IBC protocol process," said J. Patrick Guider, Jr., president and chief executive officer of TOPAZ Technologies. "Our new Biosafety Solution addresses these changing needs and is equipped with a scalable design, intuitive user interface and multi-language support for seamless global collaboration, creating a new standard in operation, cost and compliance management."
A web-based application, the Biosafety Solution integrates directly with TOPAZ Technologies product line, including Institutional Animal Care and Use Committee (IACUC) and Institutional Review Board (IRB) Solutions, to expand an organization's view of medical testing operations.
About TOPAZ Technologies
TOPAZ Technologies is a market-leading medical research software and services provider addressing the complex business, operational and compliance needs of the Life Sciences industry. Founded in 1980 and operating internationally, TOPAZ Technologies automated solutions help all segments of the medical research market transform operations for improved efficiency, compliance protection and operational insight. With a keen focus on customer service and unmatched product depth, TOPAZ Technologies has earned an expansive customer list which includes many of the largest medical testing organizations around the globe, including Pfizer, Wyeth, Emory, Duke, CDC and NIH. For more information, visit http://www.topazti.com
|SOURCE TOPAZ Technologies|
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