Award supports development of automated clinical consistency checking to strengthen safety monitoring across trial data
NEW YORK — Octozi, an AI-powered clinical intelligence platform for pharmaceutical companies, today announced that it has been awarded a Small Business Innovation Research (SBIR) Phase I grant from the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH). The award (Grant Number 1R43TR006333) will fund development of an AI-Powered Medical Review Assistant that performs real-time clinical consistency checking to improve safety monitoring and accelerate data cleaning and review in clinical trials.
Medical review remains one of the most manual and least scalable steps in clinical data operations. Medical monitors, clinical scientists, and data managers review adverse events, concomitant medications, laboratory values, and medical history across separate systems, largely by reading records and comparing them by hand. As trial data volume grows, the review burden grows with it, and clinically meaningful inconsistencies can go unflagged until late in the study, when correcting them is slowest and most expensive.
The funded work will develop and evaluate methods for surfacing clinical inconsistencies across sources in real-time that today require human cross-referencing, so that reviewers can direct their attention to the findings that matter most. Because the work involves sensitive clinical trial data, patient data protection is built into the design. Octozi's platform is SOC 2 Type II certified and built to operate under 21 CFR Part 11 and GxP requirements.
"Medical review is where clinical expertise is scarcest and the data volume is largest, and that is exactly the gap this project addresses," said Matthew Purri, PhD, Co-Founder and Chief Technology Officer of Octozi and Principal Investigator on the award. "Support from NCATS lets us do the rigorous evaluation work needed to show that automated consistency checking can hold up against how sponsors actually review data."
"Support from NCATS is critical in helping to advance novel solutions that can improve clinical research" said Amit Patel, Co-Founder and Chief Executive Officer of Octozi. "Sponsors encounter these bottlenecks in nearly every trial. Our goal is to remove those barriers slowing down drug development."
“Anyone who has done medical review knows the challenges. You are reading the same patient's data in four different places and trying to hold it in your head. The inconsistencies that matter are rarely the obvious ones. What we are building is meant to bring those to a reviewer's attention early, while there is still time to act on them." says Dr. Erik Deurell, Chief Medical Officer of Octozi, who is named as key personnel on the award and will lead the clinical evaluation of the assistant's output.
About Octozi
Octozi is a New York-based AI company building a platform for pharmaceutical sponsors to accelerate clinical development. The platform ingests data from EDC, safety, laboratory, and other clinical systems and automates data cleaning, discrepancy detection, medical review, safety reconciliation, autocoding, and reporting. Octozi was founded in 2023. Learn more at https://www.octozi.com
Funding acknowledgment
Research reported in this press release was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number R43TR006333. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
