Understanding FDA’s 2024 Draft Guidance on DMCs
The FDA's 2024 draft guidance emphasizes the critical role of independent DMCs in clinical...
FEATURED E-BOOK
Making Good Clinical Practice More Understandable
This eBook dives into GCP’s role in the clinical research ecosystem and how it protects participant rights, safety, and confidentiality.
Reporting to the IRB: Unanticipated Device Effects in Medical Device Studies
In this blog, we’ll take a look at what the regulations do and do...
Reporting to the IRB: Investigator Noncompliance
We often get questions about exactly what events should be reported to the IRB....
SAE Reporting and the IRB: Adverse Events in Drug Studies
Assessing and reporting adverse events (AEs) in clinical trials is critical to ensuring the...
Checklist to Reduce Burden on Sites and Patients
Every site is different. Learn how to meet their unique needs and make workflows...
Enhancing User Experience, Security, and Compliance with Single Sign-on
Every day, clinical research organizations work to deliver a seamless user experience for their...
IRB Review of Changes to Previously Approved Research
During the course of study conduct, most research involving human participants will require some...
Clinical Trial Efficiency: Top Risk Indicators and Solutions for Site Performance
Sponsor and contract research organization (CRO) team members such as clinical research associates (CRAs),...
Optimizing Site Initiation Timelines Through Centralized Processes
A centralized CTMS team streamlines trial initiation by uniting resources, ensuring data accuracy, and...
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