Featured Articles
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eRegBinders - Opportunities For Improvement Identified By Sites
7/10/2020
Regulatory compliance represents an increasingly demanding and difficult task for investigative sites. A recent survey comes at the perfect time to quantify this burden, identify the infrastructure to manage this burden as well as provide practical opportunities for improvement based on best practices.
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Ensuring Compliance With Part 11: A Site’s Perspective
7/9/2020
As more sites are looking to implement technology to go paperless, improve standardization, and provide secure access to essential documents, site staff ’s experience with ensuring compliance with 21 CFR 11 (Part 11) of the Code of Federal Regulations—focusing on the U.S. Food and Drug Administration’s (FDA’s) standards for electronic records and electronic signatures — may be limited. Balancing the need to maximize efficiency and ensure compliance presents a challenge, but with the right resources, the challenge is an achievable one. Gaining a better understanding of the purpose, scope, and components of Part 11 will help sites achieve their compliance goals.
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FDA Inspections Need Not Be Stressful
6/30/2020
As a stakeholder in a research facility the prospect of an inspection by the US Food and Drug Administration (FDA) may elevate your blood pressure and induce feelings of panic. But according to Dr. Harvey Arbit, "the FDA inspection process should go quite smoothly if you're doing everything right." Still nervous? Don't be.
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Understanding The Role Of IRBs In Clinical Research
6/29/2020
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. This article includes overview of an IRB, study responsibilities, as well as what the IRB wants to know.
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Steps To Paperless Clinical Research Sites
6/29/2020
This paper presents insight and expertise on how investigative sites can begin the transformation to digital documents, including concrete, practical suggestions for eliminating the inefficiencies inherent in printing, storing, and managing paper documents.
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Recruitment & Retention In Pediatric Clinical Research Trials
6/29/2020
Janelle Allen, Project Manager and Research Coordinator in the Pain Research Center at Cincinnati Children's Hospital Medical Center gives an in-depth look at best-practices that can be applied to meeting your organization's recruitment and retention goals.
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Regulatory Compliance: An Increasing Burden On Sites
6/25/2020
As the biopharmaceutical industry strives to reduce its R&D costs and shorten timelines, it must face the fact that today’s successful drug development plans often require more clinical studies than they did a dozen years ago. But a new CenterWatch survey, sponsored by Complion, sheds some light for the first time on how, and how well, sites manage regulatory compliance.
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How Leveraging Cross Collaboration Can Improve Standardization & Adoption Of An eRegulatory Solution
6/25/2020
The University of Cincinnati Cancer Institute (UCCI) collaborated with the UC Health Office of Clinical Research (OCR) to rollout an eRegulatory system based on an NCI Standard from Complion. This allowed for enhanced compliance with ability to identify trends and gather quality metrics across UCCI Disease Groups and OCR Departments to inform business decisions and process improvements.
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Texas Cardiology Research Department Transforms Document Access, Fuels Productivity
6/24/2020
What drives an established and experienced clinical research site to completely transform the way they manage regulatory and trial documentation? For South Texas Cardiovascular Consultants, PLLC (STCC) it wasn’t just about paper, it was about what paper forced us to do.
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Best Practices For Paper-Based & eRegulatory Sites
6/24/2020
This eBook examines the use of electronic tools for maintaining regulatory compliance at research sites, and recommends best practices to be applied to the use of those tools.