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?
Reporting Requirements
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.
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
Beginner’s Guide to Clinical Trial Management Systems
From the largest research centers to the smallest, sites now recognize that a clinical trial management system (CTMS) can be configured to their needs and can bring powerful efficiencies insights, and compliance to their day-to-day operations.
Diversity in Cancer Research: Getting Started
The most recent Cancer Center Support Grant (CCSG) guidelines released by the National Cancer Institute (NCI) include a new Core
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,
Navigating the FDA Emergency Use Filing Process
In an effort to create safe, effective, and affordable ventilators to help combat the foreseeable shortages due to COVID-19, one
Considerations for Transitioning from Paper to eSource
Switching from paper to eSource in clinical trials enhances data accuracy, reduces errors, and boosts organization, offering more efficient study management.
For FDA Inspection Readiness, Accountability is Key
Dawn Wydner, former Food and Drug Administration (FDA) Consumer Safety Officer, LCDR, and current Managing Expert for Advarra’s Quality Center
Q&A: FDA Updates: BIMO – What Sponsors Need to Know
Advarra experts Joan Versaggi and Leslie Paul answer questions from the first in the webinar series – FDA Updates: BIMO