Fast medical review of in-stream clinical data using a unique clinical data analysis method provides relief to busy clinicians, data managers, monitors, and project managers allowing them to focus on the bigger questions at the heart of a trial. Crucial data for trials: adverse events, labs, demography, drug exposure, drug response, concomitant medications can all be explored in a visual manner. This eliminates the need for manual listings and various associated processes resulting in 20-40% productivity increases and the savings of 3-4 days per month per trial. Spotfire enables visual data cleaning via identification of outliers on graphical displays. Such fine-grained cleaning allows for correction of data values that would have been otherwise overlooked upon first glance increasing the power of statistical tests.
Thus, data quality issues can be reduced by visually interacting with the data resulting in a 30% reduction in database lockdown preparation time while at the same time decreasing unfrozen databases by up to 50%.
Clinical users of Spotfire are empowered with actionable and fact based insights that are easy to understand via their rich, visual nature. Spotfire enables users to take questions to the next step. So not just stopping at what subjects that have out-of-range lab values but then take that information and explore those outliers to see if they are related to particular concomitant medications, drug dosage or sites through a second level on-the-fly drill down into the data. Spotfire workflows are highly interactive and can surface data from multiple datasets for sub-populations and patient level subgroups. Spotfire is highly configurable and extensible via internal workflow customization and external APIs. This enables the software to interactively report on all nuances of any given protocol - particular adverse events, out of range labs, biometric endpoints, etc. Spotfire is particularly powerful in early phase clinical studies where there are many measurements collected on a few subjects over a short period of time. Spotfire enables visualization of complex relationships between PK-PD data, biomarker data, adverse events and other patient visit data. In this setting decisions, such as dose adjustment, need to be made quickly and in context of all the data. For example the PK-PD data for a dose cohort may look favorable, but the subjects may not tolerate the dose from a safety perspective. Spotfire has an author-reviewer model utilizing lightweight viewing clients end-user review.