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Case Study

VERO Biotech Gains FDA Approval for Complex Drug and Device Combination

Learn more about how VERO Biotech leveraged Advarra Consulting to successfully navigate the pathway to FDA approval

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Blog

Research Equity and Enrolling Non-English Speakers

This blog explains how including participants with limited English proficiency (LEP) can help improve research access and diversity.

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4 min. read
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Virtual Event

Adapting, Adopting, and Succeeding in a Decentralized Landscape

Join a discussion on the exponential evolution of clinical trials, uncover trends observed across the industry, and hear how leading research organizations have adapted to a decentralized landscape.

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Blog

Understanding International Data Transfer’s Impact

Read our blog to understand some of the data privacy implications facing international clinical research.

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8 min. read
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Blog

FDA Communications Through the Drug Development Lifecycle

Understand how to effectively communicate and build a relationship with the FDA throughout the drug development lifecycle.

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5 min. read
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Info Sheet

ReadyQMS Info Sheet

Advarra ReadyQMS, a quality management system for biopharmaceutical companies, reduces risk and ensures regulatory compliance.

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Blog

Data Integrity – It’s All About the Data!

This blog dives into data integrity in clinical research, including how to obtain and maintain data throughout its lifecycle.

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3 min. read
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Blog

6 Tips for Creating Effective Clinical Trial Training

This blog offers practical tips for effective site training to ensure your global clinical trials are compliant and efficient.

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3 min. read
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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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Webinar

FWAs Part 2: Managing a Federalwide Assurance and IRB Registration

Join Advarra’s regulatory experts in another discussion of institutional and IRB responsibilities and dig deeper into the FWA topic.

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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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4 min. read
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White Paper

Ethical Issues in the Design and Review of Decentralized Research

This white paper aims to provide a framework to understand ethical issues and steps to take in deploying a decentralized trial

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