Device Risk Determinations for IVD Research
Clinical trials involving investigational in vitro diagnostic (IVD) devices are subject to the Food and Drug Administration’s (FDA’s) investigational device […]
IRB
What Are the Phases of Clinical Trials?
Each clinical trial phase builds on the last, from initial safety to post-market studies, ensuring treatments are safe, effective, and beneficial for patients.
4 Unique Challenges of Oncology Trials
Oncology trials face unique hurdles in innovation, enrollment, and endpoints, requiring strategic planning to address complex study demands and precision needs.
IBC vs. IRB: What’s the Difference?
Gene therapy research requires both IRB and IBC oversight—while IRBs protect participants, IBCs ensure community and environmental safety with local site-specific reviews.
Privacy and Confidentiality in the Age of Mobile Apps and Connected Devices
Find out what researchers should consider in selecting and using these technologies and how to adequately inform participants of the potential risks.
Improving Diversity in Clinical Trials: Strategies for Inclusive and Ethical Research
Clinical research aims to produce knowledge in the service of treating diseases and improving human health. In a just and
Full Board vs Expedited vs Exempt: Why IRBs do That
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
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, IVDs require careful IRB review preparation.
Data on the go: Mobile Application Considerations for Clinical Trials and Beyond
Explore regulatory and ethical considerations for mobile apps in clinical trials, from device regulations to consent language and IRB reviews.
How Single IRB Review Mandates Help Research Sponsors
The Food and Drug Administration’s (FDA’s) proposed single institutional review board (sIRB) mandates are in part designed to support greater
Top 3 Reasons Why Your Medical Device Needs a Clinical Trial
Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. While drugs
Unique First-in-Human Phase I IRB Considerations you Might not Know About
Explore unique IRB considerations for first-in-human Phase I trials, from informed consent to participant protections and robust incentives.