On the first day of PharmaSUG 2024 in Baltimore, Beaconcure was thrilled to announce a strategic partnership with Phastar to deliver process revolution in clinical data review. This partnership combines Beaconcure’s advanced technology with Phastar’s extensive experience and vision in the clinical data analytics domain, to streamline clinical trial development and accelerate the delivery of lifesaving drugs. Together, we are bringing much needed innovation to Clinical Review Processes.
Beaconcure Director of Statistics and Life Sciences, Steve Ross, presented “AI and the Clinical Trial Validation Process – Paving a Rocky Road,” co-authored with Beaconcure co-founder and COO Ilan Carmeli, for the Data Standards stream. The presentation attracted a sizable audience and generated interesting conversations at our booth about the role of AI and automation in clinical validation and clinical review processes.
Abstract: AI and the Clinical Trial Validation Process – Paving a Rocky Road (DS-400)
The validation of outputs in a clinical research environment acts as a guarantor process, confirming the accuracy and validity of the trial results, the investment of doctors, patients, and caregivers in the efficacy and utility of the trial, and the reputation of the sponsor and/or CRO conducting the validation. Double programming has done this heavy lifting for decades. The increasing application of AI (ML and NLP) gives statisticians and programmers unprecedented opportunity to apply this technology wherever validation takes place – during the development cycle to aid teams in getting to the right output sooner, and at the end of a study to check that tables in a package match what is expected for the deliverable.
This paper shows how to use AI and automation capabilities within Verify for activities including validating that the titles, footnotes, format, and content of the output matches the display in the mock shells, and whether big N’s, small n’s, and counts in the body of a display are logical and accurate within and across tables. This paper also illustrates a documentary audit trail that captures the end-to-end decision-making process and feedback from contributors as tables are revised from early deliverables to final. Automating critical iterative tasks can free up validation time and brainpower for statisticians and programmers to focus on the bespoke aspects of clinical trials, such as primary efficacy endpoints, complex algorithms and analyses, and ensuring that the truth of the data is told – paving the rocky road to the final product.
You can read the full paper here and view the presentation slides here.
We are honored to be participating in and presenting at multiple industry conferences this year, and offering demos at the Beaconcure booth to showcase Verify’s expanding collaboration and validation feature set. You can follow Beaconcure on LinkedIn to stay up to date on our latest announcements and events.
