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Blog

The Value of Continuity: Program-level Data Safety Monitoring Boards

Using a single Data Safety Monitoring Board for an entire therapeutic program ensures continuity and offers cost savings and efficiency gains.

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3 min. read
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Blog

Understanding FDA’s 2024 Draft Guidance on DMCs

Find out about the FDA current views regarding DMCs and the 2024 draft guidance’s implications for clinical trial sponsors.

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6 min. read
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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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Webinar

Inside Study Activation: Budgeting Takeaways

Learn how sites, sponsors, and CROs can work together to help study activation, specifically within budgeting and contracting.

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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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Webinar

Striking the Balance: Ethics, Inclusion, and Vulnerability in Research

Explore the ethical tensions between including under-represented communities and ensuring vulnerable participant populations are appropriately protected.

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Blog

SAE Reporting and the IRB: Adverse Events in Drug Studies

Explore the basics of SAE reporting to the IRB for drug studies. Learn about reportable events, FDA regulations and guidelines, and how to assess AEs.

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6 min. read
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Webinar

DSMB Best Practices and Behind the Scenes Insights

Enhance clinical trial oversight with expert insights on member selection, bias elimination, and regulatory compliance from 20+ years of leadership experience.

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Webinar

Sponsors: Are Your Sites Ready for an FDA Inspection?

Learn a comprehensive overview to prepare sponsors and sites for an FDA inspection.

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Webinar

Faster Trials, Successful Sites, Empowered Patients: Improve Your Research Experience

Optimize clinical trials with practical solutions, real site feedback, and tools for seamless success. Join our webinar to revolutionize your research approach.

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E-Book

How to Improve Your Site Compliance

Many clinical trial sites face challenges to stay compliant on a study. It is important for sites to adhere to the myriad of requirements that constitute Good Clinical Practices (GCP).

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Blog

IRB Review of Changes to Previously Approved Research

Make sure you know the IRB review requirements for amendments involving changes to IRB-approved protocols and other study modifications.

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5 min. read
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