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: Paperless Research Sites, eRegulatory, Paperless Clinical Trials, 21 CFR Part 11, Remove Monitoring

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

A Partner in 21 CFR Part 11 Compliance

Posted by Abbie Hosta on Jun 12, 2017 10:59:35 AM

How the right partner can smooth the path to a fully compliant regulatory and document management system

Efforts to transition to a streamlined paperless operation are unquestionably worthwhile. But the characteristic increases in efficiency are of little value if the transformed organization falls short of 21 CFR Part 11 compliance. That is why it is critically important that every step on the path to the paperless transformation is guided by professionals who are deeply, intimately familiar with the requirements for compliance.

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Topics: 21 CFR Part 11, Compliance, Paperless Clinical Trials, Regulatory Compliance, Paperless Research Sites

Complion Article Featured in ACRP’s Flagship Journal, Clinical Researcher

Posted by Abbie Hosta on Apr 5, 2017 10:52:17 AM

Complion is honored to have recently published an article in Clinical Researcher, the peer-reviewed flagship publication of the Association of Clinical Research Professionals (ACRP).

Clinical Researcher is published six times a year and features articles on the latest developments across the spectrum of specialty areas in the clinical research enterprise, as well as highlighting valuable insights and resources from columnists, internal and external news sources, and the Association’s partner organizations.

Written by Complion VP of Professional Services Cristina Ferrazzano Yaussy and Oklahoma Heart Hospital Senior Director James Wetzel, Ensuring Compliance with Part 11: A Site's Perspective focuses on best practices for maintaining maximum efficiency while meeting the challenges of Part 11 compliance.

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

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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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