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Webinar

Inspection Readiness: Before. During. After

Upcoming: October 13

This webinar will cover successful strategies for a proactive approach to FDA inspections before, during, and after.

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Blog

How the IND 30-day Hold Impacts Clinical Trial Activities

Find out what research activities can and cannot be conducted during the Investigational New Drug (IND) 30-day hold period.

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6 min. read
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Blog

Streamline Study Startup with Improved Site Selection & Feasibility

Identifying the best prepared and performing sites for a study is essential to success. Explore strategies to improve site selection and feasibility.

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5 min. read
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Webinar

A Guide for Successful Cell and Gene Therapy Research

Upcoming: November 1

Understand the unique regulatory, clinical, and manufacturing requirements for cell and gene therapy research.

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Webinar

Growth Mode: Developing a Fit-for-Purpose QMS Model

Upcoming: October 6

Learn successful strategies for a stepwise implementation of a clinical QMS, tailored to companies in growth mode.

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Webinar

Metrics to Increase Macro and Micro Visibility into Site Activity

Upcoming: October 4

Explore tools and metrics designed to best measure site performance and engagement on a macro and micro level.

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Webinar

Your Guide to sIRB Mandates

This webinar offers insights to your pressing questions related to single IRBs and explores the key features of federal sIRB mandates.

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White Paper

Rare and Orphan Diseases: Choosing a Path to Regulatory Approval and Market Success

Explore the regulatory challenges and pathway guidance for sponsors bringing innovative rare and orphan therapies to market.

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Blog

Regulatory, Clinical, and Quality Considerations for Device Research

Medical device manufacturers are facing increasingly complex pathways to successfully bring their innovative ideas to the market.

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5 min. read
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White Paper

What Does an Endpoint Adjudication Committee (EAC) Do?

This white paper discusses an endpoint adjudication committee's (EAC) role in clinical research and the basics of setting up an EAC.

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Blog

Regulatory and Ethical Considerations for eConsent in Research

If any part of your informed consent process involves an electronic component, you’re conducting eConsent.

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4 min. read
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Blog

An Evolving Regulatory Environment for Rare and Orphan Diseases

By 1983, only 38 orphan drugs received FDA approval. Since then, the FDA has significantly changed its approach to rare and orphan diseases.

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4 min. read
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