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.
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.
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
Advarra Expands Review Capabilities for Cosmetics Research
Early Phase Center of Excellence now includes enhanced processes and increased expertise for research involving cosmetic products
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.
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.
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.
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.
IRB Review of International Research
Advarra’s institutional review board (IRB) can support local ethics committee reviews and confirm compliance with U.S. regulations.
Understanding Various Decentralized Terms in Research
Virtual, remote, hybrid, decentralized, mHealth, telehealth: Find out what these terms mean for clinical research.
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.
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.