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eSource: The Next Emerging Category of Software

eSource is the next emerging category of software; it's the "last mile" of clinical research, where paper-based data capture can be replaced with a digital system.

The Pharmaceutical industry is actively looking for a solution, and the FDA is encouraging an electronic solution. It recently issued guidelines to encourage integration between EMR systems and EDC systems.

Transcelerate, a consortium of leading pharma companies, launched an eSource initiative with the mandate to drive adoption. The TransCelerate approach for the eSource Initiative is to understand the current landscape and highlight factors that are influencing the adoption of new technologies. As a preliminary step in this process, TransCelerate suraveyed member companies regarding eSource usage and barriers. 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."

Since 2104 thirteen companies have launched to provide solutions to this growing problem. One such company, Clinical Research IO (CRIO) launched in September 2016 (co-founded by the above Raymond Nomizu) and by January 2017 has signed up 50 research sites in North America. The company has proven that investigators are eager for a solution if it's appropriately built. CRIO will make clinical research not only more efficient, but more accurate. Users leverage a library of pre-configured templates to create custom source, building in rules, alerts, and calculations to prevent deviations. "For example," says Phuc Truong, Co-founder, "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.

The question is why eSource? There are many benefits:

eSource reduces costs by enabling remote monitoring and improving monitoring efficiency. Monitors no longer have to travel on-site and there are fewer QA requirements since, if integrated with EDC, there is no requirement to "source data verify" EDC data points.

eSource shortens product lifecycles. Because monitors don't have to fly around the country cleaning up data, the trial can do "database lock" much sooner.

eSource improves data accuracy. Paper source does not have interactive features such as pop-up help, validation alerts, skip logic, etc. that eSource does. As a result, eSource results in fewer data mistakes and protocol deviations.

Lastly, eSource saves time at the site level, allowing them to focus on more value-add activities such as recruiting or patient retention.