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

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

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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Why Now is the Right Time to Adopt eConsent

Why Now is the Right Time to Adopt eConsent

eConsent streamlines trial participation, allowing remote access and minimizing paperwork errors, benefitting both research staff...

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Streamline Study Startup with Improved Site Selection & Feasibility

Streamline Study Startup with Improved Site Selection & Feasibility

Site selection for clinical trials is often one of the biggest headaches for pharmaceutical sponsors...

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