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agSignals™
Proactive Identification and Mitigation of Safety Risk
With an increased focus by regulators on early detection and management of evolving safety trends, organizations need to use all relevant data sources to have continued insight into the benefit-risk ratio of their products.
agSignals is Aris Global's advanced data mining and pharmacovigilance (PV) signal detection system that supports in-depth clinical safety data analysis using both classical disproportionality as well as Bayesian techniques. agSignals helps organizations identify potential relationships between products and adverse events in both FDA Adverse Event Reporting System (AERS FOI) data as well as in their proprietary safety databases.
agSignals uses an optimized pharmacoepidemiological database with a robust front-end reporting tool to ensure fast and easy safety data management. Uniquely,
it also allows you to grade potential signals to
rank them in relation to the actual clinical and regulatory situation, as well as perform structured signal management using configurable workflow processes.
As with all Aris Global products, agSignals is available on premise or on demand (SaaS).
Data Mining and Signal Detection
agSignals uses a wide range of industry-standard data algorithms to enable companies to obtain consistent, reliable results for establishing a complete product safety profile. agSignals supports signal detection based on statistical criteria such as using the proportional reporting ratio (PRR) or the reporting odds ratio (ROR).
An open architecture provides connectivity with any source safety system including ARISg, allowing for the analysis of safety data and establishment of a complete and more accurate pharmacovigilance profile.
Other key features include:
- Workflow-based signal detection and management
- Access to regulatory data sets – including FDA AERS
- Capability to drill down into underlying safety data
- Support for viewing data mining results in many tabular formats (2x2, 3x3 contingency tables, etc.)
- Support for standard and user-defined trending reports
- Support for ad hoc query and report generation
Delivering Business Value
agSignals enables users to effectively aggregate, analyze, assess and act on safety signals, allowing you to proactively protect patients.
Benefits provided by agSignals include:
- Help to refine and enforce overall risk management strategies that form a part of a Risk Management Plan (RMP), Risk Evaluation and Mitigation Strategy (REMS), Safe Use Initiative, etc.
- Helps substantiate or refute causality between products and adverse events (drug-event combinations) more efficiently
- Allows effective analysis of all available safety data, including safety data of competing products from regulatory databases like FDA AERS
- Provide regulators with documentation that shows how conclusions were reached
- Build a history of assessments, analyses and actions taken to mitigate risk to patients
Contact us
Email: info@arisglobal.com
Phone: Worldwide Locations
