Insights Blog

Smart Decisions Behind a Successful FDA Inspection with eRegulatory

Posted by Abbie Hosta on Jun 26, 2018 12:30:20 PM
New Case Study Offers Insight into an FDA Inspection from a Research Site using eRegulatory 

If you find yourself standing on a railroad track, you can expect that at some point you’ll hear the distant whistle and rumble of an oncoming train. At that moment the smart decision is to step off the track in preparation of the train’s arrival.

For clinical research sites, FDA inspections are a bit like an oncoming train. They don’t whistle or rumble,  but you know they are coming. You just don’t know exactly when. The difference between getting rolled over by the inspection and surviving unscathed comes down to preparation. What are you doing to step off the tracks?

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Topics: eRegulatory, Paperless Clinical Trials, Compliance, Regulatory Compliance, FDA Inspections, Paperless Research Sites, Electronic Signatures

Leveraging eRegulatory to Improve Remote Monitoring

Posted by Sydney Shepherd on May 3, 2018 9:57:43 AM
In this day and age, we are surrounded by technology. Everywhere you look, people are checking their phones in an effort to stay connected to their friends, family and workplace. In the clinical research world, advancements in technology represent an opportunity to improve efficiency. Remote monitoring is included in this category, enabling sponsors and CROs convenient access to site documentation.
From Burden to Opportunity

Remote monitoring technology initiated by sponsors often inflicts additional burden on sites, requiring them to not only print and file their regulatory documents, but scan and upload them to multiple sponsor portals, too. However, sites are beginning to identify more efficient ways to enable remote monitoring. Empowered sites are taking control and initiating technology from their side to enhance collaboration with sponsors and streamline processes, ultimately lifting their day-to-day burden. 

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Topics: eRegulatory, Paperless Clinical Trials, Paperless Research Sites, 21 CFR Part 11, Remove Monitoring

Electronic Signatures in Clinical Research: Lifting the Paper Curse

Posted by Abbie Hosta on Oct 31, 2017 10:23:58 AM

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.

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Topics: Paperless Clinical Trials, Paperless Research Sites, Electronic Signatures

Protecting Clinical Research Documents From Natural Disasters

Posted by Abbie Hosta on Oct 23, 2017 10:48:09 AM

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.

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Topics: eRegulatory, Paperless Research Sites, Document Management

How a Texas Cardiovascular Research Department Reached New Levels of Efficiency

Posted by Abbie Hosta on Jul 5, 2017 4:38:38 PM

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.

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Topics: Paperless Clinical Trials, Regulatory Compliance, Paperless Research Sites, Document Management

A Partner in 21 CFR Part 11 Compliance

Posted by Abbie Hosta on Jun 12, 2017 10:59:35 AM

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.

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Topics: Paperless Clinical Trials, Compliance, Regulatory Compliance, Paperless Research Sites, 21 CFR Part 11

Taming the Email Beast with eRegulatory

Posted by Abbie Hosta on May 21, 2017 9:00:00 AM

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.

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Topics: eRegulatory, Paperless Clinical Trials, Paperless Research Sites, Document Management

Complion Founder Rick Arlow to Co-Host SCRS Webinar

Posted by Abbie Hosta on Apr 10, 2017 11:42:44 AM

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.

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Topics: eRegulatory, News, Paperless Clinical Trials, Paperless Research Sites, Document Management

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Complion provides clinical research sites and their sponsors with a software platform to enable secure, compliant and efficient management of documents and administrative tasks. We would love to hear from you with any questions about our Insights blog or to learn more about our software platform.

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