Using TIBCO Spotfire for Exploratory Data Analysis and Safety Assessment in Preclinical and Clinical Studies

Date Added: Jan 2010
Format: PDF

Exploratory data analysis is performed at different levels In the Novartis research and development environment, beginning at the individual study level. During a clinical study, monitoring safety biomarker trends and incidences of adverse events over time can be crucial to detect relevant safety signals as early as possible and decide on potential risk management and risk minimization steps. Using interactive graphical data analysis, experimental results can be explored either by individual scientists or in interactive team sessions, providing an opportunity to search for multi-dimensional changes in safety biomarkers, test assumptions, generate and pre-test hypotheses, and define a set of plots optimally suited to display relevant safety findings.