Intuitive Case Report Review and Data Mining
CVW Spontaneous manages sources of single-case adverse event reports (ICSRs) for use in signal detection and evaluation. It provides the safety evaluator with efficient access to define and visualize case series and to document the results of a signal investigation. It supports the receipt and versioning of cases from both internal and public sources (such as FDA FAERS) and implements an expandable set of signal detection methods and a configurable set of alerting rules.
- More Efficient Analyses –The CVW Case Series Explorer makes it easy for users to understand and navigate cases rapidly with interfaces to create and refine multiple case series and to save analyses and results sets helping to reduce time on rework.
- Intuitive & Innovative Signal Detection – An integrated signal visualization environment provides a variety of graphical displays for users conducting case reviews; an expandable set of signal detection algorithms and a configurable set of alerting rules delivers comprehensive proactive signal detection.
- Easy Integration with Multiple Data Sources – Mechanics of data loading and data mining runs are automated including interfaces to in-house spontaneous adverse event and public sources, such as FDA FAERS.
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 and learn more about how CVW helps you meet current and future signal detection needs, contact us.