In an assisted fluid management device study, physicians in surgery were prompted via algorithm when to provide subjects with fluids. These lengthy, open-abdomen surgeries generated a tremendous amount of data points for every second of each procedure.
Because of the size of the data files, no out-of-the-box solution could be utilized. The ARG team had to create both a process and system to aggregate a true data transfer in a compiled format.
ARG IT was able to aggregate data for hundreds of surgeries in just over one minute for each subject.
In a QA-validated process, the spreadsheet data was downloaded from Veeva Vault into zip files. From there, the data was put into SQL load format and uploaded to a Google Cloud SQL database. Safety controls were added to flag incomplete or incorrect information.
To make the data accessible and consumable, ARG IT made a searchable, filterable viewing platform. This dashboard provided the Sponsor organized access to the aggregated data.
By automating the process, data outliers were identified and corrected. The potential for human errors was all but eliminated.
The skill sets of ARG domain experts combined with leading tools and technologies turned this study challenge into a study strength.