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CAMBRIDGE, MA - A new clinical research e-source system aims to replace paper with tablet-based data collection. Clinical Research IO (CRIO) is a website and Android app that allows users to conduct visits on a tablet or desktop, design source online, manage and schedule subjects, and communicate with study monitors remotely.
Co-founder Raymond Nomizu, who owns and runs Beacon Clinical in Quincy, MA, has experienced the pitfalls of a paper-based system first-hand: “I have always been frustrated by the endless binders and stacks of paper at my clinic. My coordinators would have to worry about accidentally skipping over some part of a procedure. A monitor’s post-it note would fall out of a binder and get missed. I felt there must be a better way.”
In 2015, Nomizu teamed up with Phuc Truong, a serial entrepreneur who had most recently worked on a mobile health care app and thought that tablet technology could be applied to clinical research. The new company received funding from Rally Ventures and NXT Ventures - and launched at its first site in September 2016.
Nomizu says that the response to the system has been enthusiastic: “My coordinators can’t believe how much easier this is. They can punch everything into the tablet, they know when it’s complete, and everything is easy to find later.”
CRIO will make clinical research not only more efficient, but more accurate, adds Truong. Users leverage a library of pre-configured templates to create custom source, building in rules, alerts, and calculations to prevent deviations. “For example,” says Truong, “say you had an exclusionary BMI for your study. You could have your coordinator measure the height and weight of a subject, the system would calculate their BMI automatically, and an alert would pop up letting you know if the BMI was too high. It’s the kind of thing you might not catch right away if you did it on paper.”
The system also allows for remote monitoring. Rather than having to physically travel to a site, a monitor can log in to view a visit as soon as it is completed and post virtual “sticky notes” for the coordinator to respond to. Monitors can also view automatically-generated ICF, Screening, and Subject ID logs, as well as an audit trail of any edits made to source. The system is both Part 11 and HIPAA compliant.
“It’s really a game-changer for the industry,” says Truong.
To learn more, visit CRIO online at www.clinicalresearch.io.