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Blog

Informed Consent Changes in the Revised Common Rule

If your research must comply with the revised Common Rule, you’ll need to update the way you write ICFs to meet the new requirements.

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Blog

Do I Need to Comply With the Revised Common Rule?

While many US researchers are aware of the coming Common Rule changes, not everyone is sure whether they will need to comply with the revised regulations.

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Blog

Reporting to the IRB: Serious Adverse Events (SAEs) in Drug Studies

Learn what the regulations say about IRB reporting requirements for serious adverse events and how undefined “gray areas” can be addressed.

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Blog

Infection Control and Biosafety in Gene Therapy Research

Given the growth in gene therapy research, sponsors, CROs and sites have become increasingly curious about the requirements to be able to conduct such studies.

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Blog

Integration Update: Leading Compliance Adherence

The Advarra team is proud to announce that all major integration activities are now complete.

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Blog

ICH-GCP Guidelines and Research Conducted in the US

Learn the basics of how ICH-GCP Guidelines can impact the study ICF and how we at Advarra came to our updated policy on the topic.

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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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Blog

The GDPR and Its Impact on the Clinical Research Community (Including Non-EU Researchers)

Please note that this material is provided for informational purposes only and not for the purpose of providing legal advice.

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7 min. read
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Blog

Integration Update: Recent Milestones Completed

The Advarra team has worked to fully integrate our processes and policies to provide clients with unified capabilities and support for IRB, IBC and global research quality and compliance consulting services.

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Blog

Integration Update: Expanded FAQ for Advarra Merger Efforts

The following FAQ expands upon previous FAQs we’ve published and provides additional insight into the integration process.

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15 min. read
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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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Blog

Clinical Research Acronyms and Abbreviations You Should Know

New to clinical research? Learn the meaning of common industry acronyms and abbreviations including eCRF, IIT, PI, TMF, and more.

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