Pharmacovigilance
Drug safety is mission critical work in drug development. Activities in this area are being driven by regulatory agencies that increasingly require the exploration of novel methods of analysis in order to ensure the safety of new drugs. DecisionSite® provides a unique environment for evaluating safety data. Through multiple visualizations, analysts can uncover associations between an adverse event and a particular patient demographic. The ability to rapidly browse and filter the data within visualizations that update in real time provides quick answers to questions and brings attention to problems that may have been missed in the past. Early detection of safety problems is a critical activity that DecisionSite can facilitate."One of the best visualizations in DecisionSite that we use is a 3-D graphic of lab value by a drug exposure parameter, such as Cmax or AUC, by the time that lab value was recorded relative to day of first dose. This allows you to simultaneously see clustering or patterns of the lab value by exposure and by time. It's quite powerful. Many of these analysis would be too tedious to set up and perform in other applications. These analyses can be readily performed using Spotfire DecisionSite. There are definitely relationships that can be identified in DecisionSite that a spreadsheet analysis can't show you. DecisionSite is valuable to signaling adverse events. It lets me analyze the data in more detail."
- James Buchanan, Senior Director, Drug Safety, Nuvelo, Inc.
Contact Spotfire for Faster Identification of Safety Issues at your organization
Webcasts
- Improving Clinical Safety Data Signal Detection at Tularik with Spotfire DecisionSite
- Join Dr. Patricia Ruppel: Strategies for Analyzing Clinical Efficacy Data in Spotfire DecisionSite
- Accelerating the Discovery of Critical Adverse Event Patterns in EDC Clinical Trial Data
- Analyzing Adverse Events in Spotfire DecisionSite
Success Stories
Downloads
Solutions Overview: