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Webinar

Don’t Get Caught Off Guard: Inspection Readiness for Sponsors and CROs

Discover strategies for proactively assessing compliance for an FDA Inspection Readiness visit. Address deficiencies and implement corrective actions.

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Blog

Device Risk Determinations for IVD Research

Learn the FDA's investigational device exemption requirements for clinical trials involving investigational in vitro diagnostic devices.

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5 min. read
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Blog

Phases of Clinical Research: A Detailed Overview

Gain a comprehensive understanding of the various phases involved in clinical research, their objectives, and outcomes that ensure safe and effective clinical treatment.

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6 min. read
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Blog

4 Unique Challenges of Oncology Trials

Oncology research is unique in many ways, including the challenges researchers face in conducting cutting-edge trials.

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5 min. read
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Page

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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4 min. read
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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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5 min. read
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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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5 min. read
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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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5 min. read
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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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