Relsys Introduces Argus PV(TM)
Relsys International, the leading developer of adverse event reporting software for the pharmaceutical industry, today introduced Argus PV(TM), an enhanced version of its Argus
Safety(R) software solution that provides a complete, integrated environment for pharmacovigilance and risk management.
“Pharmacovigilance is quickly becoming recognized as an integral part of the risk management strategies of forward-thinking pharmaceutical companies,” said Dave Bajaj, President and CEO of Relsys. “We’ve taken the best adverse event reporting software in the industry, and added new features and functions that allow these companies to create and manage customized pharmacovigilance programs, which will help them minimize risk, and increase operating efficiencies over time.”
Pharmacovigilance systems help pharmaceutical companies minimize risk by analyzing contextual data relating to adverse event reporting, and detecting areas of potential risk earlier than traditional methodologies. When built on sound business processes, pharmacovigilance systems can mine multiple data sources to prioritize potential issues, assess performance against similar
cases in the database using the MedDRA hierarchy, build a knowledge base against which to measure future drug performance, issue early alerts, and even escalate issues based on predetermined business rules. Integrating adverse event reporting software such as Argus Safety into pharmacovigilance practices gives pharmaceutical companies timely, relevant data that can be used to mitigate risk.
Argus PV enables companies to stay in compliance with the FDA’s “Guidance for industry good pharmacovigilance practices and pharmacoepidemiologic assessment,” and has been designed to be flexible enough to allow pharmaceutical companies to develop their own, unique pharmacovigilance processes. The software includes specialized collection forms to allow
targeted lines of questioning, single-click querying for similar cases, data mining tools that can be used interactively or set up to alert at predetermined thresholds and a repository which accepts information from outside systems and can serve as a central knowledgebase for PSUR generation, labeling changes and knowledge transfer.
“Software alone isn’t the answer to a company’s pharmacovigilance needs,” added Bajaj. “But a software solution such as Argus PV can serve as the backbone for a pharmaceutical company’s pharmacovigilance practice by providing a centralized environment, and automating the processes. All of this is geared towards helping companies improve their products, reduce the
risk of product recall and liability exposure, and most importantly, ensure public health.”
Argus PV Features
Argus PV provides many features that are critical to implementing a successful pharmacovigilance program. These include:
* Targeted lines of questioning with specialized collection forms
* Temporal visualization of date-based case information
* Optional causality algorithm for uniform objective assessments
* Automated alert detection
* Workflow separate from case processing and expediting
* Data mining tools for statistical analysis
* Case series workup environment
* Signal analysis report preparation environment
* Multiple levels of escalation and notification
* Management monitoring tools and reports
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 .
