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Study Startup

Advarra's study startup solutions empower sponsors, CROs, and sites with processes, experts, and integrated technology to accelerate study and site activation.

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Blog

IBC vs. IRB: What’s the Difference?

Gene therapy research is full of promise, but because of the risks, it’s a highly regulated space requiring oversight by an institutional biosafety committee (IBC).

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Blog

Data Safety Monitoring Boards Facilitate Ethical Research

Data safety monitoring boards (DSMBs) ensure research participants are protected and results are valid. Learn about DSMB composition, concerns, charter, and challenges.

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Podcast

Decentralized Clinical Trials and Regulatory Changes

We discuss the evolution of decentralized trial modalities and possible solutions to regulatory challenges.

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Blog

Improving Diversity in Clinical Trials: Strategies for Inclusive and Ethical Research

Learn practical strategies on how to improve diversity in clinical trials for historically under-represented groups.

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Blog

Beginner’s Guide to IRB Review of IVD Research

If an investigational in vitro diagnostic (IVD) device is used in clinical research, it may require IRB review.

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White Paper

Data on the go: Mobile Application Considerations for Clinical Trials and Beyond

Find out the necessary regulatory and ethical considerations when utilizing an app or connected device in human subjects research.

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Webinar

Privacy and Confidentiality in the Age of Mobile Apps and Connected Devices

Discover how to protect participant privacy in mobile-app-based clinical research. Learn about risks and what IRBs need to consider in protocol review.

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Webinar

Full Board vs Expedited vs Exempt: Why IRBs do That

A discussion on what IRBs must consider, what might tip the scales for a study that could go either way, and what “expedited review” means.

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Blog

How Single IRB Review Mandates Help Research Sponsors

The proposed single IRB mandates will impact FDA-regulated research, potentially altering existing practices at organizations.

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Blog

Top 3 Reasons Why Your Medical Device Needs a Clinical Trial

Interpreting evolving regulations for medical devices is a common challenge for emerging biotech companies.

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White Paper

Unique First-in-Human Phase I IRB Considerations you Might not Know About

An institutional review board (IRB) may ask some different questions for first-in-human (FIH) Phase I trials than later phase studies.

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