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.
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.
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.
Head of Pharmacovigilance Operations, Boehringer Ingelheim