Insights Blog

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

5 Crucial Considerations for Selecting a CTMS

Posted by Lauren Miceli on May 29, 2018 9:00:00 AM

The best word to describe the day of a clinical research coordinator would probably be ‘hectic’. Working at a clinical research site can be stressful; from managing patient appointments to tracking study documents, professionals tools designed to simplify tasks and improve productivity are critical.

A clinical trial management system (CTMS) can streamline the daily activities and boost the overall financial health of clinical research site. By providing your research site with a CTMS, you can more efficiently manage the day-to-day operations of running a clinical trial. Furthermore, using a CTMS gives clinical research organizations the ability to easily organize their trial data in one central location.

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Topics: CTMS, Billing Compliance

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

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, 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

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: Electronic Signatures, Paperless Research Sites, Paperless Clinical Trials

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

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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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