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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.

When Are Adaptive Designs Best Suited for Oncology Trials?

Adaptive study designs are best suited for oncology clinical trials when meaningful uncertainty exists and…

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Why We Funded AI Ethics Education for Research Oversight —and Left the Agenda to PRIM&R

As AI becomes part of research workflows, the people responsible for ethical oversight need opportunities…

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Types of Audits in Clinical Trials

Clinical trial audits are independent quality assurance evaluations of trial activities, records, systems, facilities, and…

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Q&A with Advarra’s Senior Director of IRB Services Christy Frey 

Christy Frey has spent nearly two decades helping research move forward—ethically, efficiently, and always with…

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Male scientist in a laboratory, examining samples and taking notes.

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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