Insights Blog

eRegulatory Buyer's Guide: A 38-Point Checklist for Choosing the Right Solution

Posted by Complion on Aug 21, 2018 12:46:07 PM

Download your at-a-glance guide to choosing an eRegulatory solution.

As a research coordinator or administrator, being buried under a mountain of paper files is something that doesn’t have to happen often before the light bulb in your head suddenly glows with the realization that there must be a better way.

Light bulbs are clicking on in similar fashion across the industry, and their accumulated illumination is shining on eRegulatory systems. The rate at which organizations are adopting eRegulatory systems makes it quite clear that it’s only a matter of time before the eRegulatory bandwagon shows up in your site’s parking lot.

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Topics: Document Management, Paperless Research Sites, Regulatory Compliance, Paperless Clinical Trials, eRegulatory, Electronic Signatures, Standardization

University of Cincinnati Cancer Institute Abstract Awarded 1st Place for 10th Annual AACI CRI Meeting

Posted by Abbie Hosta on Jul 3, 2018 2:39:48 PM

As recently announced by the Association of American Cancer Institutes, an abstract created in a collaboration by the University of Cincinnati Cancer Institute and Complion has been awarded first place by the AACI CRI steering committee and selected to be presented in formal sessions at the 10th Annual AACI Clinical Research Initiative Meeting, July 11-12, in Chicago.

Selected from among a record 68 submissions, the winning entry, “Building a Strong Foundation: How Leveraging Cross Collaboration Can Improve Standardization and Adoption of an eRegulatory Solution,” was written by Trisha Wise-Draper, MD, PhD; Justin Osborne; Benjamin Quast, MBA, CCRP; Emily Werff, all from the University of Cincinnati Cancer Institute, and Michael Hurley, MBA, of Complion.

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Topics: Standardization, Regulatory Compliance, eRegulatory, Cancer Center, News, Document Management

Rowing in the Same Direction: Integrating eRegulatory and CTMS Systems

Posted by Abbie Hosta on Nov 13, 2017 9:17:18 AM

In summer months you can look down from one of the bridges spanning the Cuyahoga River here in Cleveland, Ohio to see rowing teams seated in slender rowing shells, slicing through the murky water. In each shell team members pull on their oars, propelling the sleek craft with remarkable speed and efficiency. Of course, that speed is possible only when everyone rows in cadence, and in the same direction.

That same level of coordination and integration is absolutely essential for the technologies on which clinical research organizations rely to manage regulatory and other essential trial information. Without that integration organizations can’t move forward, facing unnecessary duplication of effort, interrupted communication flow, and other costly, time-consuming obstacles.

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Topics: eRegulatory, CTMS, integration, Document Management

Bio-Optronics and Complion Announce Integration to Unify Best-in-Class CTMS and eRegulatory Solutions for Clinical Research Organizations

Posted by Complion on Nov 12, 2017 11:31:02 AM

Complion_BioOptronics_Partner.pngNovember 11, 2017 – ROCHESTER, NY – Bio-Optronics, the makers of the market leader Clinical Conductor Clinical Trial Management System (CTMS), and Complion, the powerful eRegulatory and document management platform for sites, have partnered to integrate their best-in-class solutions to deliver an industry-leading solution for research organizations.

The companies are building upon their long-standing commitment to meet customer needs and develop innovative solutions to empower investigative sites to run the world’s best research. This integration introduces a highly robust application suite, enabling research organizations to operate efficiently and profitably, while maintaining compliance with 21 CFR Part 11, HIPAA, and Good Clinical Practice (GCP).

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Topics: CTMS, eRegulatory, News, Billing Compliance, Document Management, Regulatory Compliance

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: Document Management, Paperless Research Sites, eRegulatory

Tough decisions? See into your eRegulatory future at 2017 Global Site Solutions Summit

Posted by Abbie Hosta on Sep 12, 2017 12:43:33 PM

In life and in business, so many tough decisions would be so much easier to make if you only had the ability to see into the future. But in the real world, the best you can do is to draw on the experience of others who have faced similar critical decisions, learned what works and what doesn’t, and applied those lessons to shape your decision.

For most sites the transition to an eRegulatory system is not a matter of if, but when. Fortunately, you have a unique opportunity to draw on the experience of panel of professionals who have completed that transformation at the 2017 Global Site Solutions Summit, taking place October 6-8, 2017 in Boca Raton, FL.

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

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

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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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