One of the best parts of being in the bioanalytical space is having the opportunity to help develop and implement change to improve how we support clients drug development needs. KCAS has engaged with Ariadne to evaluate their software, Red Thread and its AI capabilities to support quality review of reports and data. KCAS elected to conduct this quality assessment due to the recent changes in the guidance requirements from the FDA. The goal was to continually advance the reliability to produce quality reports and data.
We’re committed to using Artificial Intelligence (AI) software to help us efficiently provide quality data and reports and avoid preventable issues with the regulatory agencies. Ariadne’s Red Thread AI software can review data tables and wording from individual reports. Using Red Thread’s proprietary design, it aids the reviewers in review of data and reports. For example, it will alert the user of an item that may not be properly filled out. It does not correct the item, but it highlights the issue so the author of the report is notified that an item may need to be corrected prior to going into QC and QA within the organization). KCAS has been able to couple this with our in-house processes to produce top tier quality data and set of reports for our clients that is continually raising the bar for CRO industry providers.
What led KCAS to this was work with clients in a previous life, where I initially met the team at Ariadne and they demonstrated how their system worked. There, we collaborated to produce a mock report and data that tested if Ariadne’s Red Thread AI software could detect subtle ‘differences” or planned erroneous entries. Their application detected and identified these differences – not in hours or days – but in minutes. This test demonstrated that Ariadne’s Red Thread AI software could quickly check review the report and the data, which resulted in improved turnaround times for QC/QA review, reduced regulatory finds, and improve the quality of reports and final dataset for our clients.
This led to a few of our clients to evaluate Ariadne’s Red Thread software on reports that had already been submitted to a regulatory agency. The software was able to detect issues with those submitted reports and the client resubmitted the corrected reports to the agency. Since then, we have been informed the US regulators are evaluating this type of AI software for review of report to increase output. Based on these experiences, we at KCAS have implemented this AI software for many of our other clients.
It is a seamless process. We send the Red Thread team our reports and they evaluate them – the data and language within the reports, etc – and give us back a series of red light, green light, and yellow “flags” on all the information. It’s important to make clear that Red Thread does not change anything; they simply send it back to us with their findings and suggestions, if applicable. We then review the AI software findings, make adjustments and modifications if necessary, and then it goes to KCAS QC for review. This investment is how KCAS’s improves the quality of our product and clients avoid delays with submission due to quality issues. Delays due to the quality or data and reports can take weeks and sometimes months to resolve. By utilizing Ariadne’s Red Thread AI software alongside our other time-tested processes and quality checks, KCAS has been able to reduce the time it takes to QC/QA review data and reports.
KCAS is always looking for tools and industry-tested resources like Red Thread to increase our client experience and reduce risk and costs. With the addition of AI software KCAS continues to implement advanced quality checks that provide our clients with more confidence in reports and data. Ariadne has been providing services and products to the industry now for nearly ten years. The US FDA recognizes that AI software used for review of reports and datasets is exceptional and we at KCAS are raising the bar for providing high quality data in a cost effective and timely manner.
To read more about the approach KCAS took to evaluate the effectiveness of Ariadne’s Red Thread software, click here to download a paper we did with them within the last year on these processes and the results we found.
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