Advarra Blog

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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.

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Frequently Asked Questions About Investigator-Initiated Trials (IITs) 

Investigator-initiated trials (IITs) play a critical role in advancing clinical research by allowing investigators to…

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2026 DHHS Unified Agenda: Four Areas HRPP and IRB Leaders Should Watch

The U.S. Office of Information and Regulatory Affairs (OIRA), within the Office of Management and…

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2026 DHHS Unified Agenda: What Clinical Operations and Study Startup Teams Should Watch

Planned changes outlined in the U.S. federal government’s 2026 Regulatory Plan and the Unified Agenda…

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2026 DHHS Unified Agenda: What Clinical Research Leaders Need to Know

On July 3, 2026, the U.S. Office of Information and Regulatory Affairs (OIRA), within the…

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The Belmont Report Still Shapes How IRBs Protect Human Research Subjects Today

With all the buzz recently on regulatory reform for institutional review boards (IRBs), it’s worth…

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SIV Training Part 3

A Better SIV Model Starts by Separating the Common from the Unique 

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…

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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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