Insights Blog

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

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

Clinical Site Regulatory Processes: The Case for Standards

Posted by Paul Baechtold on Jun 18, 2018 9:00:00 AM
“Uncontrolled variation is the enemy of quality.” 

-- William Edwards Deming 

The concept of standards is not new.

People throughout time, in all eras, geographies, and industries have looked to create standards as a way to improve efficiency and reduce variance of outcomes.

For instance, King Henry I of England standardized measurement in 1120 AD by instituting the ell, which was equivalent to the length of his arm. Another example is that the Egyptians were the first to develop the 365-day calendar and are often credited with logging 4236 BC as the first year in recorded history. In 2009, a cross-section of life science companies, contract research organizations, technical vendors, industry groups and others established the Trial Master File (TMF) Reference Model to develop a standardized taxonomy and nomenclature for organization of TMF content.

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Topics: eRegulatory, Standardization, Automation

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

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, Document Management, integration

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

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

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

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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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