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Blog

Navigating the FDA Emergency Use Filing Process

Partnering with Advarra, one nonprofit successfully obtained an Emergency Use Authorization from the FDA within five weeks.

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Blog

Considerations for Transitioning from Paper to eSource

Explore the benefits of switching from paper to eSource, tips for implementation, and how to maintain compliance.

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Podcast

James Riddle and Willie Muehlhausen Discuss Digital Technology and Virtual Data Collection in Clinical Research

In this episode, we discuss the growth of decentralized clinical trial technology and how IRBs evolved to account for technology advancements.

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Blog

For FDA Inspection Readiness, Accountability is Key

An Advarra expert provides insight in this Q&A session on the FDA inspection readiness process, including how to improve current workflows.

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Blog

Q&A: FDA Updates: BIMO – What Sponsors Need to Know

Advarra experts Joan Versaggi and Leslie Paul answer questions from the webinar- FDA Updates: BIMO – What Sponsors Need to Know.

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Blog

Maintaining Data & Reporting Integrity with Mobile Health

Understand how to properly handle and evaluate incoming data gathered using mobile health (mHealth) apps and technologies.

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Info Sheet

SiteIQ

SiteIQ leverages site performance and patient availability insights to gain unparalleled visibility into site performance

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Blog

Encouraging Site Centricity and Collaboration at Onsemble

At the 2021 Fall Onsemble Conference, attendees learned about putting site centricity and collaboration at the helm of research operations.

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Blog

The Importance of Keeping DSMBs Independent

By ensuring the DSMB is truly independent from study conduct, sponsors make trial data more trustworthy and enhance public confidence.

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Infographic

US Medical Device Regulation 101

Speed the review process by understanding how medical devices are classified & what the IRB must review to approve device research.

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Blog

IRB Review of Phase I Research: Balancing Ethics and Efficiency

Find out how to address Phase I research challenges to enable efficient IRB review and timely study startup.

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Blog

Understanding eSource, ePRO, and EDC

eSource, ePRO, and EDC are integral to efficient clinical research. This blog explores how they work together and their differences.

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