IRB
How Single IRB Review Mandates Help Research Sponsors
The proposed single IRB mandates will impact FDA-regulated research, potentially altering existing practices at organizations.
Top 3 Reasons Why Your Medical Device Needs a Clinical Trial
Interpreting evolving regulations for medical devices is a common challenge for emerging biotech companies.
Unique First-in-Human Phase I IRB Considerations you Might not Know About
An institutional review board (IRB) may ask some different questions for first-in-human (FIH) Phase I trials than later phase studies.
Diving into Single IRB Implementation
In this episode, we get an inside look at how institutions implement sIRB requirements and how to overcome potential challenges.
Sickle Cell Disease: The Importance of Amplifying Patient Voices
Sickle cell disease significantly impacts the African American population, a minority community historically underserved by clinical research.
NIH 2023 Data Management and Sharing Policy: What you Need to Know
Optimizing Your Data Management Plan: Best Practices for Biomedical Research under the NIH Data Sharing Policy
What is a Quality IRB Review?
Measuring IRB quality is often an effort to determine whether an IRB’s actions improve research participant protections.
Trend Report: 2023 Trends Impacting Clinical Research
This report defines 2023 clinical research trends and provides an outlook for the industry moving forward.
Privacy Regulations Impact on Global Clinical Trial Endpoint Adjudication
Endpoint adjudication committees must keep up with rapidly developing requirements as they receive potentially identifiable research data.
How to Optimize Your sIRB Experience
Find out how other institutions have used sIRB requirements as an opportunity to elevate their research programs in this webinar.
SubjectWell Features Advarra Experts James Riddle and Luke Gelinas in White Paper
In a recent article, SubjectWell interviewed Advarra's James Riddle and Luke Gelinas, Compensation norms create inequity in clinical trials".
Updated Advarra Fee Schedules Now Available
TAdvarra’s updated fee schedules for IRB, IBC, DMC, and EAC are now available. The new fee schedules are effective January 1, 2023.
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