IT Case Study
ARG Rescues Phase I Oncology Trial Using TrialVista® ARG Manages Large Volumes of Device-Generated Data
In an assisted fluid management (AFM) device study, physicians in surgery were prompted via algorithm about when to provide subjects with fluids (to keep them stable and minimize adverse events). These open-abdomen surgeries, which were a minimum of two hours and often many hours longer, generated a tremendous number of data points for every second of each procedure. The challenge was that 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 that was never modified in the life of the study, the spreadsheet data, which originated on USB-drives, was downloaded from Veeva Vault into zip files. From there, the data was put into SQL (Structured Query Language) load format and loaded to a Google Cloud SQL database. In addition, safety controls were added so that if a subject’s data was incomplete or incorrect, a flag would be raised and communication could be initiated with the Sponsor. Finally, 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.
What Are ARG’s Advanced IT Capabilities?
ARG IT is noteworthy in the industry because although we have strategic partnerships with leading technology providers, we also maintain systems neutrality.
The ARG team demonstrated its hallmark flexibility by using innovation to solve a problem. Staying on time and using fewer resources, the ARG solution was not only cost-effective but very reliable. By automating the process, data outliers were identified and corrected, and 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.