Insights Blog

Complion Customer Receives “Exceptional” Rating from National Cancer Institute

Posted by Jason Beder on Sep 25, 2018 4:38:42 PM

One of the most rewarding, exciting, and humbling aspects of the work we do here at Complion is that it allows us to engage with organizations that are leading the charge to develop new therapies to treat patients suffering from a range of ailments. Some exciting recent news puts one of our clients into the spotlight.

The National Cancer Institute (NCI) has awarded the Robert H. Lurie Comprehensive Cancer Center of Northwestern University the highest possible rating on the competitive renewal of its Cancer Center Support Grant. Along with the recognition for the excellence of its research programs and patient care, the Lurie Center will nearly $31.5 million in funding, a 36% increase over the previous award.

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Topics: Cancer Center, NCI, eRegulatory

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

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

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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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