Advarra Blog

Ways to Streamline Informed Consent Process in Clinical Trial Startup

Optimizing the informed consent process is critical for accelerating clinical trial startup while maintaining compliance and participant understanding. This article explores key strategies for streamlining informed consent, including leveraging electronic consent (eConsent) solutions, standardizing templates, and improving collaboration between sponsors, sites, and IRBs. By implementing these best practices, research teams can enhance efficiency, reduce delays, and improve the participant experience in clinical trials.

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Q&A Part 1 – Evaluating Payment to Participate in Research: Ethical and Regulatory Issues

In a recent webinar, Dr. Luke Gelinas, IRB Chair at Advarra, provided a framework for…

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Protocol Feasibility to Promote Trial Efficiency

Scientific abstracts and articles have reported that 20-50% of studies do not accrue subjects at…

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

Study activation data from the Forte community shows on average, it takes about six months…

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How Research Informs the COVID-19 Response

Research doesn’t just inform medical treatment; it informs public health and public policy, and it…

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

In this blog we discuss unique issues that research involving emerging infectious diseases like coronavirus…

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Are “Virtual Trials” Mainstream Yet?

While some completely virtual trials are taking place, the real trend involves bringing virtual trial…

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Key Biosafety Considerations for Coronavirus Research

The recent outbreak of the novel 2019 coronavirus in Wuhan, Hubei Province, China, has led…

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

After multiple delays, exceptions, and oh-so-many training sessions, on January 20, 2020, we reached the…

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Beyond the Regulations: More Considerations for Emergency Research

In this blog post we go beyond the regulatory requirements and examine three other key…

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Most Popular Blogs of 2019

As we near the end of 2019, let's take a look back at the blogs…

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Reporting to the IRB: What NOT to Report

Despite clarification from FDA and OHRP, many of the "potential" unanticipated event reports IRBs receive…

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Making Sense of the New HUD Guidance

For almost a decade, the FDA guidance on humanitarian use devices (HUDs) dated July 8,…

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Advarra Blog

FEATURED Post

Ways to Streamline Informed Consent Process in Clinical Trial Startup

Q&A Part 1 – Evaluating Payment to Participate in Research: Ethical and Regulatory Issues

Protocol Feasibility to Promote Trial Efficiency

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

How Research Informs the COVID-19 Response