Insights Blog

Q&A Follow-up from “What ICH E6(R2) Really Means for Research Sites!”

Posted by Mary McGuire, GCP Auditor on Behalf of Polaris Consultants on Nov 13, 2018 2:05:02 PM

Polaris Compliance Consultants was delighted to present Complion’s October 24th webinar, “What ICH E6(R2) Really Means for Research Sites!” Far more questions were submitted during the webinar than we could address during the Q&A period, so we would like to answer them here. It was interesting to see that most of the questions related to documentation and document retention. That can be a confusing area for study sites. We hope you find these responses helpful.

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Topics: GCP, Document Management, Compliance, Regulatory Compliance

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

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

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

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

Q&A from Document Management Success: A Guide to Part 11 System Validation

Posted by Cristina Ferrazzano Yaussy on Aug 2, 2017 3:03:33 PM

The following is based on the Question and Answer portion of “Document Management Success: A Guide to Part 11 System Validation,” a Complion webcast featuring Michelle Grienauer, JD, MPH, Senior Regulatory Attorney at Kinetiq, and Cristina Ferrazzano Yaussy, MPH, CCRP, VP of Professional Services, Complion, Inc. The webinar explored what clinical research sites should know about validating eRegulatory and document management systems. 

366 individuals from the clinical research industry attended: 31% from an Academic Medical Center, 23% from a Hospital or Health System, 12% from a Dedicated Research Site, 11% from a Cancer Center, 7% from a Physician Practice, and 5% from a Sponsor or CRO. Prior to the webinar, the audience was polled to collect feedback about the current state of document management and validation.

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Topics: Compliance, Regulatory Compliance, 21 CFR Part 11, eRegulatory

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

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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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