Insights Blog

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

Mightier than the Sword, but Killing Efficiency

Posted by Complion on Mar 12, 2018 11:06:20 AM

New Webinar Examines Opportunities to Streamline Regulatory Processes with eSignatures

A pen is great for jotting down a quick reminder on a sticky note. Pens make great gifts for associates, and are inexpensive and effective swag at business conferences. You probably have a drawer full of pens in your desk, and at this very moment a pen may be staining your shirt. But that innocuous, ink-filled stick nestled in your shirt pocket can be an enormous obstacle to productivity and efficiency for your clinical research site.

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Topics: Electronic Signatures

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

Electronic Signatures in Clinical Research: Lifting the Paper Curse

Posted by Abbie Hosta on Oct 31, 2017 10:23:58 AM

Scenes of someone being relentlessly pursued, perhaps by zombies, vampires, flying sharks, or some combination of any or all of the above, are common on TV during Halloween season. And that’s ok. But somewhat similar scenes are also playing out in the halls of research facilities as research nurses or regulatory coordinators attempt to chase down busy Primary Investigators (PIs) whose signatures are needed on essential documents. Staff members set up ambushes, pen and documents in hand, waiting for unsuspecting PIs. Or they set out the documents where they hope the PIs will see and sign them, which only increases the chances that the documents will disappear.

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Topics: Paperless Clinical Trials, Paperless Research Sites, Electronic Signatures

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

Q&A from "Best Practices for Participant Safety: Assessment Documentation and Reporting of Adverse Events"

Posted by Complion on Aug 18, 2017 10:10:53 AM

The following was provided by the audience question and answer session that was part of the Complion webinar, “Best Practices for Participant Safety: Assessment, Documentation & Reporting of Adverse Events,” featuring Elizabeth Ness, MS, BSN, RN at the Center for Cancer Research, NCI, Ilana Logvinov, RN, MSN, CCRP at Mayo Clinic College of Medicine, and Yolanda McKinney, RN, BSN, CCRC at the Center for Cancer Research, NCI.

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Topics: Compliance, Safety Reporting, Adverse Events

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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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