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Blog

Reporting to the IRB: Unanticipated Device Effects in Medical Device Studies

What do the regulations say about unanticipated device effects and IRB reporting? In this blog, Advarra addresses unique requirements for medical device studies.

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2 min. read
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Blog

Reporting to the IRB: Investigator Noncompliance

Find out what the regulations say about reporting noncompliance to the IRB and how IRBs have addressed the undefined gray areas.

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3 min. read
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Blog

How Centralized IBC Review Can Benefit Gene Therapy Research

Understand the risks and regulatory requirements for gene therapy research and how a biosafety review can benefit this type of research.

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4 min. read
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Webinar

FDA/OHRP Harmonization and Your HRPP Operations

This webinar will discuss the human research protection program (HRPP) opportunities and challenges through FDA and OHRP harmonization.

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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

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

Protocol Feasibility to Promote Trial Efficiency

Many studies do not accrue subjects at the site level, which contributes to a significant amount of waste of staff time and monetary resources. Read more:

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8 min. read
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Blog

Study Activation: A Complex Process That Doesn’t Have to Be Painful

If the clinical development time of a new treatment is to ever decrease, reducing the time in study activation is necessary so actual research can be done.

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3 min. read
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Blog

How Research Informs the COVID-19 Response

Research doesn’t just inform medical treatment; it informs public health and public policy, and it helps explain human behaviors. Read more:

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5 min. read
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Blog

IRB Review of Coronavirus and Other Emerging Infectious Disease Research: Issues to Consider

Advarra IRB experts discuss unique issues that research involving emerging infectious diseases like coronavirus can raise for IRB review. Read more:

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5 min. read
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Blog

Revised Common Rule Compliance Now in Full Effect—and What That Means

The Revised Common Rule is here after multiple delays, exceptions, and many training sessions. As of January 20, 2020, this regulation is in full effect.

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3 min. read
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