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Blog

GxP Audits Guide for Successful Clinical Trials

Ensure GCP compliance throughout your clinical research lifecycle with a comprehensive guide to GxP audits.

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6 min. read
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Blog

Impact of sIRB Mandates on Study Teams

May 16, 2024

Much has been written about the impact of single institutional review board (sIRB) mandates on local IRBs and human research...

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6 min. read
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Blog

Planning for Complex Change at Your Organization

Navigate the ever-changing landscape of innovation and technology in clinical operations by discovering strategies to help your organization.

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5 min. read
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Blog

Interim Staffing: Reinvigorating Your Human Research Protections Program

Uphold research compliance best practices with an innovative approach to HRPP.

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Blog

The Value of Continuity: Program-level DSMBs

Using a single DSMB for an entire therapeutic program ensures continuity of experience and offers potential cost savings and efficiency gains.

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3 min. read
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Blog

Understanding FDA’s 2024 Draft Guidance on DMCs

Find out about the FDA current views regarding DMCs and the 2024 draft guidance’s implications for clinical trial sponsors.

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Blog

Reporting to the IRB: Investigator Noncompliance

Find out what the regulations say about reporting noncompliance to the IRB and how IRBs have addressed the undefined gray areas.

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Webinar

Striking the Balance: Ethics, Inclusion, and Vulnerability in Research

Explore the ethical tensions between including under-represented communities and ensuring vulnerable participant populations are appropriately protected.

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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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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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Webinar

Navigating sIRB Complexities: An Interactive Session

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

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Webinar

DSMB Best Practices and Behind the Scenes Insights

Enhance clinical trial oversight with expert insights on member selection, bias elimination, and regulatory compliance from 20+ years of leadership experience.

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