Real-world examples of how a clinical research sites are turning to eRegulatory to manage email correspondenc and run more efficiently.
Despite your best efforts to keep your email inbox clear, it can easily become overstuffed as your day to day correspondence pours in. That’s a problem. But that problem takes on massive significance when that email correspondence is part of the documentation in a clinical trial and subject to FDA regulations with specific requirements for how that correspondence is organized and managed. Printing and filing hard copies of email correspondence only exacerbates the problem.A growing number of research sites are taking advantage of features in the Complion's eRegulatory platform to tame the email beast.
Neal Surasky is the data manager and quality assurance coordinator for the Chesapeake Research Group near Baltimore, Maryland. CRG is focused on post-bunionectomy analgesic trials, and has recently expanded to include post-abdominoplasty studies.
“I’m the kind of guy who, once we start doing something, I want to jump in all the way,” Neal admits. His enthusiasm helped to drive CRG’s rapid adoption of Complion’s correspondence management and storage features. “The correspondence is key,” Neal says.
CRG’s standard process requires that every follow-up letter from a monitor is reviewed and signed by that trial’s PI. Complion easily streamlined that process. “Uploading those documents and sending them through correspondence is really, really helpful,” Neal explains, “However, one of my favorite features is the add-on for Microsoft Outlook. With this add-on, every single email can be sent from my Outlook into the system and directly into the specific binder for that particular trial.”
That feature has eliminated the need for Neal to manually review and organize countless paper documents. “That all goes away with this system,” he explains. ”It’s just uploaded immediately, and it’s so easy.”
The feature is particularly valuable in situations involving correspondence that applies to more than one study. “If you have a sponsor for which you are running two different studies at the same time and one email refers to both of them, it’s so easy to just send it to both binders rather than make copies and file them in two different regulatory binders,” Neal explains.
The days of needing two or three four-inch binders to hold correspondence for a single trial are gone. ”Complion makes it all go so, so easy,” Neal says. He describes a recent situation in which a monitor for a study that had just closed asked for all of the correspondence for that trial so she could upload it to her sponsor’s master file. “In about five minutes, rather than having three, four binders worth of stuff, all the correspondence for the entire study from the time it began to the time it closed was saved in a single 150 megabyte file that I could just put up on an FTP site and send to her. It was amazing.”
While CRG initially thought the electronic system might cause difficulties with audits, those difficulties never materialized, thanks to the system’s ability to download all trial information into a single file. “I really appreciate the system for that,” Neal says.
Want to learn more about how Complion is helping Neal Surasky and the Chesapeake Research Group?