Does Your CRO Automate its Validation Processes?

ARG Automation

  • Leverages technology to automate hundreds of test steps
  • Eliminates human error while saving time and money
  • Uses the time gained to focus on additional aspects of the patient journey

ARG understands that time and quality process improvements have significant downstream effects on major study deliverables. When a database goes live after the first subject is enrolled, average data entry turnaround times are delayed throughout the course of the study; additionally, database lock takes 75% longer to complete. By using a smarter automated approach to clinical data validation, we are able to cut down build timelines as well as identify and correct more errors prior to go-live. This allows us to reduce negative impacts on data entry and hit milestones down the road.

ARG reduces what was typically over eight hours of work for a highly skilled programmer or data manager completing hundreds of test steps to less than 30 seconds. Given that traditional validation is prone to human error (especially after hours of staring at a screen), the ARG program provides relief by uncovering errors that are difficult for the human eye to see. This automation produces accuracy and repetition without fatigue.

From a technical standpoint, the code performs “compares,” specifically between the Database Design Specification (the planned design and field attributes) and the EDC Data Dictionary (the actual design and field attributes). For each of the two input files the program creates a table in memory that contains key/value pairs where the “key” is a combination of field values that can uniquely identify a row of data. Once the tables are constructed, the program looks at each key/value combination in both tables and then reports on both matches and non-matches.

Creating key/value pairs in tables in memory and then comparing those pairs is not new in Information Technology; however, the application of the compare process is new within ARG to assist Data Management in performing rapid compares in an efficient and repeatable way.

From a value perspective, the additional benefit of this approach is using the hours gained to focus on other parts of projects. We capitalize on time previously spent on technical validation to take a more holistic view of the clinical database with real-world perspectives. Stakeholders can help ensure that the database tells the whole story of the patient’s journey in the study. Each type of user is able to enter and review the data with ease, including CRAs, biostatisticians, investigators, and potentially even data entry staff from participating sites.

ARG’s use of technology to improve how rare disease, immunology, and oncology clinical trials are managed not only saves time and money and improves accuracy, but also can shift the focus to better partnering with sponsors to positively affect the lives of patients.

(Photo by Jude Beck)