IRB
Study Startup
Advarra's study startup solutions empower sponsors, CROs, and sites with processes, experts, and integrated technology to accelerate study and site activation.
IBC vs. IRB: What’s the Difference?
Gene therapy research is full of promise, but because of the risks, it’s a highly regulated space requiring oversight by an institutional biosafety committee (IBC).
Data Safety Monitoring Boards Facilitate Ethical Research
Data safety monitoring boards (DSMBs) ensure research participants are protected and results are valid. Learn about DSMB composition, concerns, charter, and challenges.
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.