A top 10 global biopharmaceutical company clinicians were using an inflexible clinical study data review tool that forced them to review clinical study data in a very rigid workflow centered around reports deemed by clinicians to not be useful. This, coupled with the time it took to simply select their studies in the system, caused the clinicians to abandon the use of the existing clinical data review system and instead rely on the creation of customized summary tables, line listings and graphics. The clinicians turned to Excel spreadsheets and paper reports for the medical review of data. As a result, hundreds of pages of line listings were printed at a time, taped together, while using highlighters to mark records and analyze the clinical data.
The company paid enormous amounts of money to data management firms to extract, piece together, format and deliver the clinical data via email. This process was very labor intensive and slow. For a ten-week study, an entire week was spent by a data manager to simply generate and deliver the line listings for a study. After the data was delivered and brought into Excel, the clinicians had a very difficult time visualizing the relationships and trends in the data.
The company deployed Revvity Signals Software's interactive data visualization and analysis solution to their clinicians and safety reviewers as part of a safety review tool that is quickly becoming the tool of choice for clinical data review.