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Blog

Enhancing Research Conduct Using eConsent

The Belmont Report established informed consent parameters in 1976, but there are no federal regulations surrounding electronic consent.

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Blog

5 Questions to Ask Your Sponsor for DCT Implementation

Sponsors are uncertain about how to design a DCT to ensure efficient performance delivery, learn how to set your organization up for success.

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4 min. read
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Blog

Clean Bench vs Biosafety Cabinet: What’s the Difference?

Using hoods with biological materials depends on directional airflow, and specialized airflow is necessary when handling hazardous materials.

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Blog

Regulatory Considerations for Pharmaceutical Product Lifecycle Management

New FDA guidance (ICH q12) applies to pharmaceutical drug substances and products requiring a marketing authorization.

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Blog

CBD Research: A Dive into the Regulations of Cannabis Research

With cannabis usage becoming more popular, there’s an uptick in research surrounding its therapeutic effects.

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3 min. read
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Blog

What is an sIRB and Why Does my Study Need One?

Federal requirements have shifted to require most multisite clinical trials to rely on a single IRB for trial oversight.

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Blog

Q&A: The IND Journey Phase I – Navigating Success

Advarra experts Sharon Ayd and Leslie Paul answer questions from their webinar, The IND Journey Phase I – Navigating Success.

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9 min. read
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Blog

Short Form Consents and the Unexpected Non-English Speaking Participant

What happens when an unexpected non-English speaking participant shows up, and there isn’t enough time to obtain a translated study consent?

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3 min. read
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Blog

Beginner’s Guide to eTMF, eISF, and Regulatory Research Documents

Global & FDA regulations dictate how researchers organize & store trial documents. Learn the basics of eTMF & eISF clinical research tools

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Blog

Return of Research Results to Study Participants

Research into participant experiences has consistently shown their desire to learn the results of research to which they’ve contributed.

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4 min. read
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Blog

Expanding the Ecosystem to Better Serve You

June 30, 2022

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Blog

Common Pitfalls in Preparing an IND Application

While the IND application process may be straightforward to some, we explore the most common pitfalls as sponsors prepare for submission.

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6 min. read
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