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Blog

A Phased Approach to QMS

A phased approach to quality management systems (QMS) ensures quality is embedded at every stage, from discovery to post study.

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Blog

Thinking About the Box: Considerations for Transport of Investigational Products

Ensure safe transport of investigational products with meticulous planning and rigorous procedures to mitigate hazards and uphold biosafety.

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Blog

Clinical Trial Startup: Insights from the Industry

Clinical research professionals provide relevant insights into challenges and barriers impeding study start up.

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Blog

The Role of Financial Management and GAAP in Clinical Research

Learn how robust financial practices and a CTMS aligned with GAAP principles can drive sustainable growth and efficiency within an organization.

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Blog

Navigating CAPA in Clinical Development: Ensuring Compliance and Quality Assurance

A robust corrective and preventive action (CAPA) stands as a critical tool for proactively addressing deviations in clinical research.

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Blog

Enhancing Research Ethics: Understanding HRPP Staffing and the sIRB Mandate

Understand the significance of HRPP staffing despite an sIRB mandate, and how HRPP staffing maintains ethical research practices.

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Blog

What is a Data Monitoring Committee?

In a complex clinical trial, data monitoring committees oversee interim data to ensure adequate safety monitoring.

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Blog

GxP Best Practices for Safer, Smarter, Faster Clinical Research

Uncover key regulations and insights regarding GxP in pharmaceuticals, medical devices, and clinical research.

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Blog

Beginner’s Guide to Human Research Protection Programs

A robust institutional HRPP plan includes a comprehensive compliance framework and experienced staff focused on protecting research participants.

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Blog

Optimizing Your Human Research Protection Program: The Role of Quality Training

Having a robust human research protection program (HRPP) in place is vital when maintaining compliance and keeping participants safe.

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Blog

What is an sIRB and Why Does my Study Need One?

Federal requirements have shifted to require most multisite clinical trials to rely on a single IRB (sIRB) for trial oversight.

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Blog

Public Perceptions of Clinical Trials: A Comprehensive Survey

In a complex and competitive climate, we sought the understand existing perceptions surrounding clinical research trials.

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