Key Features/Benefits

Real time safety profile employing multiple sources simultaneously

Unparalleled qualitative and quantitative tools for data analysis and signal detection

Lifecycle management from safety intelligence to assessment to risk management planning and effectiveness measurement

Harmonize business process and achieve end to end traceability from sources to actions

Bridge operational gaps between Pharmacovigilance and Regulatory affairs 

Reconcile safety data across sources for in-depth benefit-risk assessment

Streamline regulatory communications and submissions

GVP compliant modules for Risk management, Signal management, Additional monitoring and Safety communications

signal detection in drug safety pharmacovigilance

Background

There is an evolution in drug safety as organizations shift focus from single case processing and reporting to comprehensive surveillance. Unknown and missing associations that could be discovered from multitude of sources need to be effectively dealt with and communicated in timely manner.

Along with the challenges of screening signals from disparate sources, comes the necessity of having a structured framework in place to effectively process emerging risks without burdening safety teams. Signal detection, Benefit-Risk assessment, Risk minimization planning and Effectiveness measurement activities can not be carried out in silos any more if the overall goal is to ensure that medicinal product continuously demonstrates healthy benefit-risk balance through out its lifecycle.

agBalance™ - Integrated Signal Detection & Benefit Risk Assessment

ArisGlobal's agBalance offers an integrated technology solution for the safety intelligence, signal management and risk mitigation processes of medicinal products. Through its systematic approach, the solution empowers the safety science group in proactively identifying the safety issues, continuously assessing their impact on benefit-risk profile and effectively mitigating risks across the product's lifecycle. While improving the safety governance and process efficiency, this advanced platform facilitates the incorporation of comparative Benefit-Risk concepts in novel therapeutic areas' strategy and existing safety planning and their usage throughout the development and commercial lifecycle to ensure product's competitive positioning and longevity.

Key Features

Seamless integration with any safety database

Access to FDA FAERS, VAERS, MAUDE, PMDA Japan, Literature and Social Media sources

Support for aggregate analysis, data mining, text analytics, visualization and dashboard

GVP compliant signal management

Support for novel Benefit-Risk models

Support for Risk Management Planning and Distribution

signal detection in drug safety pharmacovigilance