Decentralized Clinical Trials and Regulatory Changes
We discuss the evolution of decentralized trial modalities and possible solutions to regulatory challenges.
Improving Diversity in Clinical Trials: Strategies for Inclusive and Ethical Research
Learn practical strategies on how to improve diversity in clinical trials for historically under-represented groups.
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.
Data on the go: Mobile Application Considerations for Clinical Trials and Beyond
Find out the necessary regulatory and ethical considerations when utilizing an app or connected device in human subjects research.
Privacy and Confidentiality in the Age of Mobile Apps and Connected Devices
Discover how to protect participant privacy in mobile-app-based clinical research. Learn about risks and what IRBs need to consider in protocol review.
Full Board vs Expedited vs Exempt: Why IRBs do That
A discussion on what IRBs must consider, what might tip the scales for a study that could go either way, and what “expedited review” means.
How Single IRB Review Mandates Help Research Sponsors
The proposed single IRB mandates will impact FDA-regulated research, potentially altering existing practices at organizations.
Top 3 Reasons Why Your Medical Device Needs a Clinical Trial
Interpreting evolving regulations for medical devices is a common challenge for emerging biotech companies.
Unique First-in-Human Phase I IRB Considerations you Might not Know About
An institutional review board (IRB) may ask some different questions for first-in-human (FIH) Phase I trials than later phase studies.
Diving into Single IRB Implementation
In this episode, we get an inside look at how institutions implement sIRB requirements and how to overcome potential challenges.
Sickle Cell Disease: The Importance of Amplifying Patient Voices
Sickle cell disease significantly impacts the African American population, a minority community historically underserved by clinical research.
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