IT Case Study

ARG Rescues Phase I Oncology Trial Using TrialVista® ARG Manages Large Volumes of Device-Generated Data

Challenge

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.

Solution

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.

  • Extensive experience using Google’s GSuite and Cloud Platform, as well as Amazon Web Services to create system automations and integrations
  • Extensive experience working with technical and non-technical sponsor teams to solve unique and unanticipated trial challenges
  • In-house expertise to take advantage of the Application Programming Interfaces (APIs) on the Medrio, Medidata RAVE, Quick Base, Veeva, Paylocity, and many other third-party platforms
  • Use of cloud-based systems since 2006
  • Extensive experience with low-code cloud based platforms to rapidly build, validate, and deploy unanticipated sponsor requested applications to facilitate clinical research
  • In-house expertise using the top 3 programming languages within IT: Python, Javascript, and SQL to extend the capabilities of cloud-based platforms.
  • In-house expertise integrating Sponsor systems with our own for automated data exchange
  • Ability to deliver sponsor data through web-based portals or automated data exchanges
  • Ability to implement an Investigator Site Portal using the Veeva’s suite of unified clinical operations applications
  • 15+ years of experience building EDC study databases
  • 5+ years of experience utilizing eTMF systems
  • Early adopter of Veeva Unified Clinical Platform (CTMS + eTMF)
  • Business Intelligence and Analytics with Grand Central Data

Moving Forward

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.

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