An essential aspect of running an effective clinical study is continuously assessing patient level and aggregated safety data during the study’s conduct. This core need is extremely well served with Spotfire. Relationships in the data can be visually obtained allowing for graphical comparisons of indicators such as safety versus dosing, drug exposure, and concomitant medications. For clinical development to proceed more efficiently, clinical development organizations are simplifying and streamlining clinical data management and analysis processes.
TIBCO Spotfire Clinical including Spotfire interactive visualization and S+/R predictive analytics - enables proactive, responsive decision making, rather than retrospective tracking of results. Such proactive decision making can shorten the time between critical
development gates and enable key milestones to be met sooner, while simultaneously managing safety risk. Live analysis of study data including interactive review/analysis of adverse events, labs, vitals , etc. can be performed. In-built statistical analysis for assessing AE treatment emergence can be performed using methods such as trees and forests. The seamless connection between Spotfire and S+/R can enable PK exposure-response and survival analysis.
“Interactive graphical data exploration provides an efficient, powerful and flexible tool to improve both detection and systematic assessment of safety signals”
Michael Merz, MD, Head Safety Networks, Novartis