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Blog

SAE Reporting and the IRB: Adverse Events in Drug Studies

Explore the basics of SAE reporting to the IRB for drug studies. Learn about reportable events, FDA regulations and guidelines, and how to assess AEs.

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6 min. read
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White Paper

sIRB Review for Multicenter Research: A Guide for Institutions

February 15, 2024

Single IRB (sIRB) review for multicenter research is fast becoming the norm in the US. Initiative such as the NIH sIRB policy and revised Common Rule make it clear that ...

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Blog

Enhancing User Experience, Security, and Compliance with Single Sign-on

As technology evolves and the industry streamlines research workflows, implementing SSO can lead to significant improvements in both user experience and security.

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5 min. read
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Webinar

Navigating sIRB Complexities: An Interactive Session

Upcoming: March 26

Join us as we share insights, strategic priorities, and guidance for preparing your institution for sIRB mandates.

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Webinar

Sponsors: Are Your Sites Ready for an FDA Inspection?

Upcoming: February 29

Learn a comprehensive overview to prepare sponsors and sites for an FDA inspection.

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Blog

IRB Review of Changes to Previously Approved Research

Make sure you know the IRB review requirements for amendments involving changes to IRB-approved protocols and other study modifications.

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5 min. read
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Blog

Optimizing Site Initiation Timelines Through Centralized Processes

Learn how to optimize clinical trial initiation with centralized processes, intuitive intake forms, and custom reporting and streamline workflows for efficiency.

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3 min. read
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Blog

mRNA Cancer Vaccines and Therapies: An Overview

Learn about mRNA’s potential impact on cancer research, the technology’s unique challenges, and strategies for researchers developing mRNA-based cancer studies.

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4 min. read
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Blog

Implementing eSource: A Guide for Operations and Technology Roles

Explore the transformative power of eSource in clinical research, streamlining data collection for efficiency and cost savings.

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4 min. read
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Blog

How Sponsors and Sites Work Together to Improve Protocol Compliance

As trials continue to increase in complexities, sites and sponsors must work together to minimize deviations and cause for FDA findings.

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4 min. read
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Blog

Addressing Industry Challenges: Staff Turnover

Staff turnover can greatly impact the quality and progress of an organization’s clinical trials and research projects.

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3 min. read
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