Sites
Regulatory Fine Points: What Research Sites Need to Do for Part 11 Compliance
Summary of James Riddle's Presentation at SQA, which outlines considerations for sponsors when ensuring 21 CFR Part 11 compliance at sites.
What Is an Institutional Biosafety Committee?
An institutional biosafety committee (IBC) ensures research is conducted safely and in compliance with the NIH guidelines. Watch our video to learn the role of an IBC.
Building a Foundation for Regulatory Success in the Post-Pandemic Landscape
Read how an eRegulatory system can increase productivity, improve compliance, and ensure a return on your technology investment.
What is Coverage Analysis in Clinical Research?
This infographic outlines the importance of coverage analysis, consequences to non-compliance, and solutions to avoid non-compliance.
Q&A: FDA Inspections of Clinical Investigators: Understanding the Process and What to Expect
Q&A from our 4/21 webinar outlining what to expect in an FDA inspection and how to have a more positive experience.
Q&A Part II with Dr. Wendy Tate, Author of Insights Accrual Prediction Algorithm
This March, Insights Accrual Prediction platform was released to pilot customers. The second issue of our Q&A series continues our conversation with Dr. Wendy Tate, the author behind the machine learning tool’s algorithm, to hear her experience bringing this innovative tool to the research community and get her perspective on what comes next.
Q&A Part I with Dr. Wendy Tate, Author of Insights Accrual Prediction Algorithm
This March, Insights Accrual Prediction platform was released to pilot customers. We sat down with Dr. Wendy Tate, the author behind the machine learning tool’s algorithm, to learn what inspired her to tackle this industry hurdle and hear her experience bringing this innovative tool to the research community.
Building Remote Workflows within eRegulatory Document Management: Subject Binders & SOPs
Advarra eRegulatory Management System now supports the storage and remote monitoring of Subject Binders and SOPs, increasing compliance, and centralizing your study documents.
Understanding the Complexity and Uniqueness of Phase I Trials
There are many distinctions that set Phase I trials apart from the rest. For sites aiming for a successful Phase I trial, working with an organization that understands the nuances is key.
mRNA and Its Role in Clinical Research
Messenger RNA (mRNA) has made recent headlines due to its role in Operation Warp Speed. This article explores how its technology is used to fight the COVID-19 pandemic.
Does Warp Speed Vaccine Development and Testing Compromise Safety?
Fiction often shows warp speed travels not going as planned, but what does warp speed mean for vaccine development in clinical research?
Top 10 Educational Resources of 2020
We strive to create meaningful and relevant content for the clinical research community. Check out our top resources of 2020.
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