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?
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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
It’s Time for Sites to “Bring Your Own Technology” (BYOT)
Sites gain control with Advarra’s BYOT approach, eliminating redundant tasks and fostering efficient collaboration between research stakeholders and participants.
Critical Steps for Writing an Impactful Clinical Audit Report
The amount of detail required in an audit may vary – ranging from an executive, high-level summary with detailed observations,
The Advantages of Outsourcing IRB and IBC Reviews to One Partner
Gene therapy studies are a relatively recent addition to the world of clinical research. As a result, the unique requirements
Understanding Various Decentralized Terms in Research
As many research organizations are becoming more patient-centric and adapting to technological advancements and remote requirements, they are re-designing the