Latest Posts by Barry
IRB Review of Changes to Previously Approved Research
Make sure you know the IRB review requirements for amendments involving changes to IRB-approved protocols and other study modifications.
mRNA Cancer Vaccines and Therapies: An Overview
Learn about mRNA’s potential impact on cancer research, the technology’s unique challenges, and strategies for researchers developing mRNA-based cancer studies.
How Sponsors and Sites Work Together to Improve Protocol Compliance
As trials continue to increase in complexities, sites and sponsors must work together to minimize deviations and cause for FDA findings.
Beginner’s Guide to Human Research Protection Programs
A robust institutional HRPP plan includes a comprehensive compliance framework and experienced staff focused on protecting research participants.
Understanding Various Site Use Cases for eSource and EDC
Utilizing a comprehensive, site-centric eSource or electronic data capture (EDC) platform can streamline a site’s data capture, management, and compliance.
What Sponsors Need to Know About Medicare Coverage Analysis
Discover the role of MCA in clinical research, its impact on study activation timelines, and how outsourcing can streamline trials.
In this podcast, we discuss our predictions and perspectives on the 2023 clinical research trends.
Embracing Changes to the Clinical Research Workforce
In this episode, we discuss workforce challenges in the clinical research industry and the impact of the great resignation.
My Favorite Case Study: COVID-19 Applications for Monkeypox
How the COVID-19 pandemic has shaped vaccine development, promoting accelerated research for conditions like monkeypox.
Beginner’s Guide to IRB Review of IVD Research
If an investigational in vitro diagnostic (IVD) device is used in clinical research, it may require IRB review.
eReg Benefits for Clinical Research: Use Cases for all Types of Sites
Using an eRegulatory system can benefit any site, helping to increase productivity, improve compliance, and save money.
NIH 2023 Data Management and Sharing Policy: What you Need to Know
Optimizing Your Data Management Plan: Best Practices for Biomedical Research under the NIH Data Sharing Policy