Impact of sIRB Mandates on Study Teams
As sIRB mandates reshape the clinical trial landscape, study teams must navigate unique challenges...
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.
Strategic Training: Navigating Organizational Challenges
Training is crucial for changing employee behavior, but not every issue requires it. Identifying...
Key Items Auditors Look for When Reviewing an Investigator Site File
Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical...
Planning for Complex Change at Your Organization
The only constant in clinical research is change. Researchers are always innovating, making it...
Interim Staffing: Reinvigorating Your Human Research Protections Program
Interim staffing offers HRPPs specialized expertise, fresh perspectives, and support for accreditation and structural...
The Value of Continuity: Program-level Data Safety Monitoring Boards
In the realm of pharmaceutical development, ensuring the safety and efficacy of new treatments...
Understanding FDA’s 2024 Draft Guidance on DMCs
The FDA's 2024 draft guidance emphasizes the critical role of independent DMCs in clinical...
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....
Looking for More?
To register for upcoming webinars and see where we’ll be next, go to the Events page.
Want to see the latest news and updates about Advarra? You can find them in the Newsroom.
