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. […]
Research Compliance
Addressing Research Technology Challenges to Gain Sponsor Buy-in
At Advarra, we are passionate about enabling the industry to become more site-centric. To achieve this, it is especially important
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.
Beginner’s Guide to Clinical Trial Billing Compliance
Understanding clinical trial billing rules, from Medicare policies to state laws, is crucial for avoiding compliance pitfalls and supporting trial integrity.
Local Versus Central IRBs: What’s the Difference?
Central and local IRBs share the same research oversight goals, but NIH’s single IRB mandate challenges local IRBs to adapt their broader responsibilities.
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