Insights Blog

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

Multi-Site Trials: Streamlining Operations with eRegulatory & Document Management

Posted by Abbie Hosta on May 10, 2017 3:57:07 PM

Growth is good. Growth is healthy. But clinical research sites that rely on paper-based systems or even shared drives will quickly find that growth, particularly as it relates to managing multiple locations, can dramatically increase aspirin consumption in order to counteract headaches of truly historic proportions.

Sites that still rely on paper must manually route documents, either physically or by email, across a spiderweb of locations in an effort to collect physician signatures or to get people to sign off on reviews. That process can leave a cluttered trail of redundant documents and duplicate files, which only increases the possibility that something will go wrong, and turns that dream of increased visibility into document tracking and task assignment into a nightmare of wasted time and money.

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Topics: eRegulatory, Paperless Clinical Trials, Document Management, Multi-Site Trials

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

The Paperless Voyage: How Leading Sites Can Overcome Fear of Sponsor Resistance when Adopting an eRegulatory System

Posted by Lisa Bozza Archer on Mar 28, 2017 4:18:26 PM


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?

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Topics: eRegulatory, Paperless Clinical Trials, Regulatory Compliance, Paperless Research Sites

Steps to Paperless Research Sites: Creating Certified Copies & More

Posted by Abbie Hosta on Mar 20, 2017 3:13:39 PM

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.

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Topics: Paperless Clinical Trials, Regulatory Compliance, Paperless Research Sites, Certified Copies

Why are Sites Slow to Adopt Paperless Technologies?

Posted by Abbie Hosta on Feb 10, 2017 8:20:16 AM

What would keep clinical trial site staff from using technological tools they know to be important factors in successful trial management?

According to a recent post from ACRP, one reason is the lack of clear understanding about U.S. Food and Drug Administration regulations regarding document management in clinical trials.

“Many clinical trial practitioners believe FDA still wants to see certain documents in paper form, and it is not always clear what the agency’s expectations are.”

Another reason cited in the blog post for the foot-dragging on the adoption of electronic tools is simple human aversion to change.

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Topics: Paperless Clinical Trials

Going Paperless: A Shared Journey

Posted by Complion on Nov 1, 2016 5:12:08 PM

While your organization may be working in the shadow of a growing mountain of paper documents and regulatory binders, the prospect of transitioning to an electronic document management system can be daunting. After all, you’ve been using your current system for a while. It may be a relic, but it’s a familiar relic. You know how it works, and you know what to expect -- even though you know that a better solution is available.

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Topics: eRegulatory, Paperless Clinical Trials

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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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