Signal and Risk Management

Deep safety intelligence, delivered in real-time.

LifeSphere Signal and Risk Management

Proactively identify and manage safety issues, and easily assess their impact on a product’s benefit-risk profile across its life cycle. 

  • Real-time safety profiling by analyzing multiple data sources simultaneously
  • Unifies all data sources in a single data lake for rich safety insights
  • Advanced qualitative and quantitative methods for in-depth signal detection
  • Automates signal management with AI and Machine Learning
  • Streamlines risk management planning and distribution across countries
  • Simple, intuitive user interface for easy navigation and training


Diverse Data Sources, One Workspace

Enables organizations to simultaneously connect to both internal and external sources of safety-related data for analysis. This includes FDA FAERS, EMA EVDAS, WHO Vigibase, PMDA Japan, FDA VAERS, FDA Devices, Clinical, Literature, EMA PRAC, RWE and Social.

LifeSphere Signal and Risk Management analyzes data to identify relevant signals, and systematically manages them in a cognitive computing-enabled workflow while capturing a full range of decisions.

Industry-Leading Automation

Enabled with cognitive automation and artificial intelligence.


  • Reduce false positives and improve operational efficiency through automated signal management
  • Leverage NLP and AI technologies to prioritize safety observations, classifying signals from adverse events and bio medical literature

Streamline Safety Surveillance and Risk Management

Integrated risk management planning and distribution helps organizations to author, distribute and track risk management documents with affiliates, streamlining safety surveillance and risk management.

Built for the Cloud

Developed on modern cloud architecture, lowering total cost of ownership and offering seamlessly upgrades.

Out-of-the-Box Readiness 

The only proven and validated off the shelf solution to offer one platform for all safety surveillance needs, resulting in a more efficient drug development process and cost reductions.

Compliance Made Easy

Seamless data integration, real-time data discovery and rapid information distribution, ensuring global and local compliance.

Interactive Visualization and Analytics

Offers users an intuitive interface with advanced analytics to conduct ad-hoc analysis, drag and drop visualization and reporting. Custom role-based dashboards can be created for real time insights.

We have seen how the LifeSphere platform’s advanced robotic automation and cognitive features will allow us to automate many of our key PV steps in the area of case processing, which are currently resource intensive”.

Claudia Lehmann

Head of Pharmacovigilance Operations, Boehringer Ingelheim

LifeSphere Signal and Risk Management

Download the factsheet 

Automation in Pharmacovigilance: From Hype to Reality

Download the webinar

Cognitive Computing in PV: Revamping Drug Safety Using an Advanced Computing System

Download the whitepaper



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