Reporting Requirements
Part 11/Annex 11 Independent Audit and Compliance Assessment
Learn how the Advarra Consulting team deployed a proprietary Part 11 / Annex 11 assessment and mock inspection program.
Special Considerations for Pediatric Trials
In this white paper, get to know the key considerations for researchers conducting pediatric clinical trials.
UW Carbone Cancer Center Gains Visibility into Site Accrual with Insights
Monitoring accrual is a key responsibility for a cancer center administrator. From answering questions for leadership to preparing for a grant submission, knowing the ins and outs of a site’s accrual metrics can ensure greater operational efficiencies center-wide.
What Level of Review Does Your Study Need?
In this infographic, we share useful information for investigators to know which level of IRB review likely applies to their study.
The Challenge of Unproven Regenerative Stem Cell Therapies
Stem cell clinics with unproven treatments are on the rise in the US. Learn how the FDA is working to bring new stem cell therapies under federal oversight.
What’s the Difference Between Right to Try and Expanded Access?
Let’s take a look at the basics of what each program does and does not do for patients seeking to access investigational therapies.
IRB Services for Institutional Sites
Advarra serves as your external support and compliance partner for everything from single investigational sites to multisite research consortia and therapeutic networks.
International Research and Research Ethics Review
Clinical research continues to grow throughout the world, with researchers looking outside the US for new and diverse subject populations to help develop and improve investigational therapies. Lauri Carlile, VP of Operations at Advarra, discusses the basics of ex-US research ethics review for US-based researchers.