Insights Blog

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

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

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

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

Understanding the Role of IRBs in Clinical Research: A Quick Guide

Posted by Complion on Jan 16, 2017 8:11:37 AM

The ultimate goal of clinical research is to provide relief from, if not outright cures for, the various maladies and infirmities that plague human beings. In the ever-evolving world of research, history has shown that human frailties of another variety can sometimes send the pursuit of that goal down a less noble path. Effective regulation helps to ensure that that ultimate goal remains dominant among the many motivations that drive research.

Institutional review boards are an important example of regulatory efforts to insure the protection of the rights of human research subjects, as well as the protection of the patients who will ultimately benefit from the treatments resulting from that research.

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Topics: Clinical Research Ethics, Human Subject Protection, 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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