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
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.
signal detection in drug safety pharmacovigilance