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Case Study

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.

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White Paper

Special Considerations for Pediatric Trials

In this white paper, get to know the key considerations for researchers conducting pediatric clinical trials.

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Case Study

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.

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White Paper

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.

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Blog

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.

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7 min. read
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Blog

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.

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5 min. read
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Info Sheet

IRB Services for Institutional Sites

June 21, 2018

Advarra serves as your external support and compliance partner for everything from single investigational sites to multisite research consortia and therapeutic networks.

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Blog

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.

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3 min. read
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