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E-Book

Trend Report: 2023 Trends Impacting Clinical Research

This report defines 2023 clinical research trends and provides an outlook for the industry moving forward.

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Blog

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.

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Webinar

How to Optimize Your sIRB Experience

Upcoming: February 2

Find out how other institutions have used sIRB requirements as an opportunity to elevate their research programs in this webinar.

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News

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". 

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News

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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Blog

Your Guide to sIRB Mandates

sIRB regulations and policies have been announced and implemented to help address the challenges of conducting clinical trials involving multiple research sites.

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4 min. read
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Blog

Why Keep HIPAA Separate from the Informed Consent Form

HIPAA is important to the informed consent process, and oftentimes, a standalone document is the most beneficial approach.

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Blog

Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials

Until the 1980s, children were excluded from research studies. Now, FDA provides draft guidance on ethically including kids in trials.

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News

FDA Proposes Revised IRB Regulations, Including Required sIRB for Multisite Trials

The FDA released two proposed rules intended to partially harmonize its current regulations with the Revised Common Rule.

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2 min. read
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Blog

FDA’s September 2022 NPRMs: What They Mean for Academia and Industry

FDA’s new NPRMs would harmonize certain IRB regulations with the HHS Common Rule. Find out what this could mean for sites and sponsors.

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Webinar

Roundtable: Perspectives on the FDA Guidance for Clinical Decision Software

Clinical decision support (CDS) software is a challenging regulatory space. Conquer the confusion with this roundtable discussion.

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Blog

Unpacking IRB Innovations for Decentralized Clinical Trials

Ethical oversight committees continue to innovate to keep pace with the rapid changes and evolution of research conduct.

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6 min. read
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