A Journey in Support of Diversity
Since he was young, Sergio Armani has always found solace on the bike, spending many childhood days riding 20 miles
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The Impact of Digital Transformation in Clinical Trials
Digital transformation. We’ve heard about it for years, but now all of us have experienced a dramatic technological acceleration as
Why Device, Diagnostic, and Digital Therapeutic Research Needs Endpoint Adjudication
In its March 2006 guidance, Establishment and Operations of Clinical Trial Data Monitoring Committees, the U.S. Food and Drug Administration
Understanding the EU Clinical Trials Regulations Updates
The updated European Union (EU) pharmaceutical legislation for the Clinical Trials Regulation (CTR) entered into application on January 1, 2022.
Considerations for IRB Review: Artificial Intelligence & Machine Learning
Artificial intelligence in clinical research is expanding rapidly, bringing both excitement and ethical challenges. How can IRBs ensure responsible oversight?
DMC vs EAC: What’s the Difference?
Clinical research oversight relies on both DMCs for big-picture data review and EACs for detailed event assessments. Learn how each committee enhances trial safety.
Advarra’s Support for Institutions
As clinical research sites face more challenges than perhaps ever before, it’s increasingly important to provide sites with proper support
Beginner’s Guide to institutional review boards (IRBs)
In clinical research, institutional review boards (IRBs) a vital role in ensuring participant rights and ethical standards are upheld throughout the trial.
Keys to Advancing Your Biotech Go-to-Market Plan
For nearly 10 years, a growing biotech company worked to develop a nitric oxide and delivery device for babies in
Medical Devices: “Significant Risk” Versus “Nonsignificant Risk” Determinations
In medical device research, the determination of “significant risk” or “nonsignificant risk” is sometimes confusing, especially for those new to
Research Involving Cosmetics: What you Need to Know
The Food and Drug Administration (FDA) is a U.S. public health authority within the Department of Health and Human Services
Beginner’s Guide to Community-Based Participatory Research
With diversity, equity, and inclusion efforts currently at the forefront of the research community’s collective mind, we’re also seeing increased