Scenes of someone being relentlessly pursued, perhaps by zombies, vampires, flying sharks, or some combination of any or all of the above, are common on TV during Halloween season. And that’s ok. But somewhat similar scenes are also playing out in the halls of research facilities as research nurses or regulatory coordinators attempt to chase down busy Primary Investigators (PIs) whose signatures are needed on essential documents. Staff members set up ambushes, pen and documents in hand, waiting for unsuspecting PIs. Or they set out the documents where they hope the PIs will see and sign them, which only increases the chances that the documents will disappear.
Flooding in Houston. Wildfires in Sonoma. Utter devastation in San Juan. Natural disaster has dominated recent headlines, providing a sobering reminder of just how susceptible we are to the power of nature. Watching the news coverage of people struggling to rebuild lives, homes, and businesses, I find myself wondering if it is even possible to be prepared for such incredible destruction. There are limitations to how much you can protect yourself and your property, and given the level of destructive force on display in recent disasters, it seems the only truly viable precaution is to be somewhere else.
It’s an increasingly common occurrence at clinical research sites, that moment of realization that the organization is choking on paper. A blizzard of documents and a mountain of bulging folders crushing efficiency and slowing processes to the point that a fleeting thought about a splash of lighter fluid and a well-placed match might pass through the mind of a harried site executive.Cooler heads prevail, of course, and far less incendiary solutions are readily available.
Complion has been such a solution for a great many research sites, including South Texas Cardiovascular Consultants (STCC), a research hospital that serves patients in four locations throughout Texas.
How the right partner can smooth the path to a fully compliant regulatory and document management system
Efforts to transition to a streamlined paperless operation are unquestionably worthwhile. But the characteristic increases in efficiency are of little value if the transformed organization falls short of 21 CFR Part 11 compliance. That is why it is critically important that every step on the path to the paperless transformation is guided by professionals who are deeply, intimately familiar with the requirements for compliance.
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.
Complion Founder and CEO, Rick Arlow, along with Advanced Clinical Trials President, Jeremy Rigby, will host an educational webinar for the Society of Clinical Research Sites (SCRS) on April 25, 2017.
Earn credit for one Contact Hour by attending Embracing a Paperless Process: Best Practices for Regulatory and Document Management. This one-hour webinar will focus on best practices for electronic document management and explore strategies for saving time and money and improving compliance by connecting new eRegulatory and document systems to existing systems.
The paperless trend is sailing across the industry and continues to gain momentum. While electronic document management is becoming more mainstream in research, it is still considered uncharted territory for some sites and a voyage for others.
Some sites approach this change with trepidation, fear, and questions. Will their sponsors accept documents signed electronically, or will they balk at the mere suggestion? Will monitors resist reviewing site documents electronically? Or, worst of all, will adopting an eRegulatory system result in sponsor hesitation during site selection?
Whether you’ve taken the first steps toward a paperless clinical trial environment, or are still contemplating that very important transformation, you will want to take advantage of a new resource now available from Complion.
Steps to Paperless Research Sites: Creating Certified Copies and More, a new Complion feature article, presents insight and expertise from Betsy Fallen on using information technology to tame the paper beast that threatens efficiency and productivity at clinical research sites.
A recognized authority on the role of IT in regulatory and clinical operation and data management, Betsy’s early training as a registered nurse has kept her focus on patient welfare throughout her career. Now a regulatory and clinical process consultant, Betsy spent several years in regulatory and clinical operations with Merck and Co., along the way accumulating expertise in moving clinical trials to paperless environments.