Next Generation Signal Management System
The demands on pharmacovigilance teams have never been greater. The surveillance of post-marketed drugs includes increased global regulatory oversight and more data sources. Safety reviewers must detect problems as early as possible while minimizing time lost chasing false signals. Following up on true signals, from detection to resolution, requires numerous teams, all contributing to an effort that must be optimized, transparent and available for audit.
A Platform for Signal Management from Detection to Resolution
CVW is an integrated cloud-based signal management system supporting the detection, tracking and refinement of safety signals using evidence across multiple data sources. The experienced Commonwealth team designed CVW using innovative methods of signal detection, a modern technology architecture and user-centric design methodology to deliver safety reviewers a next generation system for managing signals from detection to resolution. CVW integrates multiple data sources including longitudinal data, Eurdravigilance reports and spontaneous data sources, has configurable workflow and streamlined ToDo lists to support, manage and track safety review processes.
- More Conclusive Investigations – Use proven, innovative signal detection methods to to identify and validate new signals
- Increased Efficiency – User and signal management-specific workflows, operational metrics and ToDo lists help optimize work processes for safety reviewers throughout the safety signal lifecycle
- Deeper Insights – Access multiple types of data sources directly including spontaneous and longitudinal data with tools designed for large clinical datasets and collaborations across teams
- Investigate – Conduct initial reviews of integrated signal alerts from multiple sources and launch deeper investigations when needed
- Spontaneous – Generate signal detection statistics, explore case series interactively and support investigations from public data sources
- Longitudinal – Detect, track and refine safety signals using evidence from large observational healthcare datasets
- Tracker – Track the workflow of signal investigations, collect analysis results, provide operational and compliance metrics for process improvement
- Analytics – Gain new insights into complex safety questions with powerful data mining and analysis capabilities
CVW modules can be used independently and in various combinations.
CVW is being used by top ten pharmaceutical companies, biotechnology firms and global regulators to explore new data sources, analyze data more effectively and implement innovative signal detection methods. To see a brief demonstration of a next generation signal management system and learn more about how CVW helps you meet current and future signal detection needs, contact us.