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Webinar

The IND Journey Phase I – Navigating Success

Explore strategies for advancing investigational new drug (IND) submissions and a comprehensive guide through Phase I of the IND journey.

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Case Study

GDPR Implementation Support

Learn how Advarra’s global consulting expertise enabled iSpecimen to implement GDPR with no service interruption to their customers.

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Blog

Pitfalls of Chemistry, Manufacturing, and Controls in Investigational New Drug Preparation

Submitting an IND application for the first time? Consider three common CMC pitfalls that may impact submission.

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3 min. read
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Blog

Good Manufacturing Practices (cGMP): When Do They Apply?

When do current Good Manufacturing Practices (cGMP) regulations apply? Read more for FDA expectations for the application of cGMP to investigational drugs:

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3 min. read
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Blog

Keep in Touch: Tips for Working with a Single IRB for the First Time

Recent regulations and policies have many institutions establishing policies and processes for working with an external sIRB. Read more:

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7 min. read
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Blog

Q&A – Ask Advarra Live: The Real-World Impact of COVID-19 on Research

We have addressed the most popular Q&A topics from our recent webinar on the research impact of COVID-19 in this blog post. Read more:

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6 min. read
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Blog

Differentiating “Public” and “Private” Internet Spaces in IRB Review

The difference between “public” and “private” internet spaces has gained importance with the growing research use of internet and social media platforms as data sources. Read more:

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4 min. read
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Blog

Meeting the Challenges of Investigator-Initiated Trials

How does investigator-initiated research differ from other types of clinical research? Advarra IRB Chairperson Robert Romanchuk explains.

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6 min. read
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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

Six Key GDPR Questions to Review

Questions still remain about GDPR and its applications. Have you considered these six key questions to ask within your organization?

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5 min. read
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Blog

Can Ethics Review Catch Up to the CBD Craze?

CBD, a non-psychoactive cannabinoid, is experiencing a massive surge in popularity, but clinical research lags behind in verifying effective uses.

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4 min. read
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