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Blog

Medical Devices: “Significant Risk” Versus “Nonsignificant Risk” Determinations

Take a closer look at what significant risk and nonsignificant risk determinations mean for medical device clinical trials.

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6 min. read
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News

Holiday Schedule – Presidents’ Day (US) and Family Day (Canada)

Advarra's US and Canada offices will be closed on February 21, 2022 due to the Presidents' Day and Family Day holidays.

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Info Sheet

IRB Review Services for Cosmetics Research

This info sheet describes Advarra’s specialized expertise, dedicated support, and rapid IRB review timelines for cosmetics research studies

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News

Advarra Expands Review Capabilities for Cosmetics Research

Early Phase Center of Excellence now includes enhanced processes and increased expertise for research involving cosmetic products

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2 min. read
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Blog

Research Involving Cosmetics: What you Need to Know

Find out how the Food, Drug, and Cosmetic Act defines cosmetics and how a test article can be subject to multiple FDA regulatory frameworks.

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2 min. read
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Blog

Beginner’s Guide to Community-Based Participatory Research

Learn what CBPR is, how it's employed, the benefits of conducting it, & how to best approach this type of research.

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3 min. read
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White Paper

Reporting to the IRB: What Does and Does Not Need to be Reported

This white paper outlines IRB reporting requirements, why reporting is important, and what should and should not be reported.

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Blog

The Advantages of Outsourcing IRB and IBC Reviews to One Partner

By utilizing a vendor that offers both IRB and IBC services in-house, sponsors can streamline reviews and enhance study startup timelines.

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3 min. read
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Info Sheet

IRB Review of International Research

Advarra’s institutional review board (IRB) can support local ethics committee reviews and confirm compliance with U.S. regulations.

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Blog

Understanding Various Decentralized Terms in Research

Virtual, remote, hybrid, decentralized, mHealth, telehealth: Find out what these terms mean for clinical research.

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4 min. read
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Info Sheet

Integrate Advarra’s CIRBI Platform and your electronic master file (eTMF) via Advarra Connect

Enabling Advarra Connect improves efficiency, reduces administrative burden, and streamlines audit readiness across your research portfolio.

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Webinar

Didn’t Expect that to Happen: Events that must be Reported Promptly to the IRB

This webinar helps researchers better understand how to evaluate potentially reportable events and what needs to be reported to the IRB.

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