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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

Key Items Auditors Look for When Reviewing an Investigator Site File

Ensure your ISF is complete and avoid findings with these examples of specifically what auditors/inspectors look for during an audit. Read more:

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Webinar

Not if, but When: A Study Manager’s Guide to Adaptability and Incoming Trends

Dive into achieving critical milestones across study startup, conduct, and close out that every project manager should optimize.

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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Understanding FDA’s 2024 Draft Guidance on DMCs

Find out about the FDA current views regarding DMCs and the 2024 draft guidance’s implications for clinical trial sponsors.

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6 min. read
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Webinar

Inside Study Activation: Budgeting Takeaways

Learn how sites, sponsors, and CROs can work together to help study activation, specifically within budgeting and contracting.

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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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3 min. read
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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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6 min. read
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Blog

Checklist to Reduce Burden on Sites and Patients

Review a list of considerations for site-sponsor tasks to streamline startup, reduce redundancy, and refine technology choices for effective partnerships.

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5 min. read
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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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Webinar

Sponsors: Are Your Sites Ready for an FDA Inspection?

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

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Webinar

Faster Trials, Successful Sites, Empowered Patients: Improve Your Research Experience

Optimize clinical trials with practical solutions, real site feedback, and tools for seamless success. Join our webinar to revolutionize your research approach.

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