Barry Onyia
Latest Posts by Barry Onyia

IRB Review of Changes to Previously Approved Research
During the course of study conduct, most research involving human participants will require some form...
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mRNA Cancer Vaccines and Therapies: An Overview
The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps...
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How Sponsors and Sites Work Together to Improve Protocol Compliance
Sites and sponsors can adopt strategies to reduce quality issues and avoid FDA warning letters...
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Beginner’s Guide to Human Research Protection Programs
Human research protection programs (HRPPs) play a critical role in protecting the rights, safety, and...
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Understanding Various Site Use Cases for eSource and EDC
Sites can improve data capture, management, and compliance using a site-centric eSource or EDC platform,...
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What Sponsors Need to Know About Medicare Coverage Analysis
With MCA processes slowing trial activation, AACI suggests sponsors play an active role in MCA...
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Beginner’s Guide to IRB Review of IVD Research
IVDs diagnose and monitor health using biospecimens, often in labs. FDA-regulated but varied in compliance,...
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eReg Benefits for Clinical Research: Use Cases for all Types of Sites
While regulatory management takes time and effort, using an eRegulatory system can help staff boost...
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NIH 2023 Data Management and Sharing Policy: What you Need to Know
In an effort to accelerate the sharing of biomedical research results, the National Institutes of...
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