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The Next Generation of CIRBI, the Technology Powering Advarra’s IRB

For more than 40 years, Advarra’s institutional review board (IRB) has been built on a simple commitment: quality, clarity, and care in every review. That commitment hasn’t changed, and it never will. What does change—what has to change—is how we deliver on it. The research community moves faster every year, and the sponsors, sites, and CROs we serve deserve oversight that is as thoughtful and rigorous as it has always been, paired with the speed, expertise, and transparency that modern research demands.

NHSR, Exempt, Expedited, or Full Board? A Plain-Language Guide to Potential Review Pathways 

Researchers often want to know early whether a study will be considered Not Human Subjects…

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Using Longitudinal Endpoint Data to Anticipate Study Complexity

When it comes to unnecessary protocol complexity, the cracks often show up later. Amendments. Delayed…

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What Is ALCOA+? A Practical Guide for Clinical Research

Clinical research decisions are only as sound as the records supporting them, and that soundness…

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What Actually Belongs in the Live SIV? 

In fall 2026, the Advarra-facilitated Site-Sponsor Consortium will release a white paper on reducing redundant site training through competency-based, role-based, and reusable training models while…

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IRB Reportable Events Checklist 

Determining whether an event requires prompt institutional review board (IRB) reporting is an important part of…

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Clinical Trial Governance: What It Is and Why It Matters 

Clinical trial governance is the framework that guides ethical, compliant, and efficient clinical research. It establishes the…

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SIV Training Is Still Too Redundant. The Data Shows Where to Start.

In fall 2026, the Advarra-facilitated Site-Sponsor Consortium will release a white paper on reducing redundant site training through competency-based, role-based, and reusable training…

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What Is the Difference Between an SAE, AE, and UADE in Clinical Trials? 

Adverse events (AEs) are untoward medical occurrences in participants receiving a study intervention, regardless of…

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Q&A with Advarra’s Senior Coordinator of Client Services Rachel Garrett 

Rachel Garrett’s career in clinical research has come full circle. After starting her journey at…

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Businessman cooperating with doctors in the hospital.

What Is the Difference Between Monitoring and Auditing in Clinical Trials And Why Do They Matter for Inspection Readiness?

Clinical trial monitoring (CTM) and auditing are both essential quality management activities, but they serve…

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Advarra AI Council Members Participate in a Panel at Northwestern University to Discuss the Impacts of AI on Biosecurity

What impact will advancements in artificial intelligence (AI) have on national security and global public…

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The Data Monitoring Committee Charter Is Now a Strategic Governance Document 

FDA’s 2024 draft guidance signals broader expectations for data monitoring committee (DMC) independence, communication, documentation, and sponsor decision-making. For sponsors…

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