Key Features/Benefits

  • Cognitive platform with machine-learning capabilities
  • Real-time safety profile employing multiple sources simultaneously
  • Unparalleled analysis, reporting, and data mining
  • Lifecycle management of risk planning and safety intelligence
  • Streamline business process for decision making
  • Gap analysis between Pharmacovigilance and Regulatory Affairs
  • Reconcile safety data across platforms for benefit-risk assessment
  • GVP-compliant modules for risk management and safety communications

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 a 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 cannot be carried out in silos any more if the overall goal is to ensure that medicinal product continuously demonstrates healthy benefit-risk balance throughout its lifecycle.

LifeSphere Safety and Risk Management™ – Integrated Signal Detection and Risk Management

As a key module of ArisGlobal’s LifeSphere Safety™ platform, LifeSphere Safety – Risk Management™ gives life sciences companies the leading technology necessary – cognitive computing / machine learning capabilities, multi-tenant cloud-based deployment and comprehensive set of qualitative and quantitative techniques for safety data analysis and signal detection to realize significant efficiencies and effectiveness across the benefit-risk process. End-to-end surveillance capabilities within a single interface enables companies to proactively predict potential adverse events across a medicinal product’s lifecycle while recording full range of decisions and reducing burden on safety science group. With a full view of the benefit-risk landscape of a given medicinal product at hand, life sciences companies can now better evaluate and make informed decisions that ultimately help ensure patient safety.

Comprehensive Capabilities

LifeSphere Safety – Risk Management™ delivers significant improvements for companies seeking comprehensive signal detection and benefit-risk assessment:

  • Smarter signal detection algorithms to reduce the noise-to-signal ratio
  • End-to-end workflow to streamline signal detection, signal management and risk management planning activities and to capture full range of decisions from identification to actions
  • A user-friendly graphical interface with advanced analytics, visualization and computational engine
  • Comprehensive reporting capabilities to support regulatory and business requirements including Compliance, Inspections, PBRER and KPIs
  • Access to FDA FAERS, FDA VAERS, FDA MAUDE, PMDA Japan, Embase, InsightMeme, Observational and Clinical Sources
  • Ability to capture and analyze social media sentiment through natural language processing (NLP) and advanced mathematical algorithms for a more-thorough assessment of product’s safety profile
  • Seamless integration with any safety database to enable rapid deployment and reduce maintenance overheads
  • Support for novel Benefit-Risk modeling techniques
  • Support for Risk Management Planning and Distribution

signal detection in drug safety pharmacovigilance