Award supports development of automated clinicalconsistency checking to strengthen safety monitoring across trial data
NEW YORK — Octozi, an AI-powered clinicalintelligence platform for pharmaceutical companies, today announced that it hasbeen awarded a Small Business Innovation Research (SBIR) Phase I grant from theNational Center for Advancing Translational Sciences (NCATS) of the NationalInstitutes of Health (NIH). The award (Grant Number 1R43TR006333) will funddevelopment of an AI-Powered Medical Review Assistant that performs real-timeclinical consistency checking to improve safety monitoring and accelerate datacleaning and review in clinical trials.
Medical review remains one of the most manual and leastscalable steps in clinical data operations. Medical monitors, clinicalscientists, and data managers review adverse events, concomitant medications,laboratory values, and medical history across separate systems, largely byreading records and comparing them by hand. As trial data volume grows, thereview burden grows with it, and clinically meaningful inconsistencies can gounflagged until late in the study, when correcting them is slowest and mostexpensive.
The funded work will develop and evaluate methods forsurfacing clinical inconsistencies across sources in real-time that todayrequire human cross-referencing, so that reviewers can direct their attentionto the findings that matter most. Because the work involves sensitive clinicaltrial data, patient data protection is built into the design. Octozi's platformis SOC 2 Type II certified and built to operate under 21 CFR Part 11 and GxPrequirements.
"Medical review is where clinical expertise is scarcestand the data volume is largest, and that is exactly the gap this projectaddresses," said Matthew Purri, PhD, Co-Founder and Chief TechnologyOfficer of Octozi and Principal Investigator on the award. "Support fromNCATS lets us do the rigorous evaluation work needed to show that automatedconsistency checking can hold up against how sponsors actually reviewdata."
"Support from NCATS is critical in helping to advancenovel solutions that can improve clinical research" said Amit Patel,Co-Founder and Chief Executive Officer of Octozi. "Sponsors encounterthese bottlenecks in nearly every trial. Our goal is to remove those barriersslowing 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 tohold it in your head. The inconsistencies that matter are rarely the obviousones. What we are building is meant to bring those to a reviewer's attentionearly, 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 andwill lead the clinical evaluation of the assistant's output.
About Octozi
Octozi is a New York-based AI company building a platformfor pharmaceutical sponsors to accelerate clinical development. The platformingests data from EDC, safety, laboratory, and other clinical systems andautomates data cleaning, discrepancy detection, medical review, safetyreconciliation, autocoding, and reporting. Octozi was founded in 2023. Learnmore at https://www.octozi.com
Funding acknowledgment
Research reported in this press release was supported by theNational Center for Advancing Translational Sciences of the National Institutesof Health under Award Number R43TR006333. The content is solely theresponsibility of the authors and does not necessarily represent the officialviews of the National Institutes of Health.