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Blog

Developing a Data-driven Feasibility Process

Assessing feasibility in clinical research is vital for success, enabling organizations to make informed decisions and ensure seamless execution and reporting of studies.

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Blog

The Regulatory Binder Checklist For Clinical Trial Sites

This checklist offers a comprehensive framework for managing all necessary essential regulatory documents efficiently.

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Blog

The Importance of Hazard Communications in Clinical Trials Involving Genetic Engineering

A formal hazard communication or IBC SOP is critical to ensure clinical personnel understand the risks involved with genetically engineered investigational products.

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Blog

Navigating Local Considerations When Developing sIRB Reliance Policies

Explore key local considerations for developing single IRB policies, and learn how to navigate the challenges- including compliance, ethical standards, and institutional requirements.

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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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Blog

Strategic Training: Navigating Organizational Challenges

It’s important to define what falls into training and what doesn’t. The key is to know what the training is intended to accomplish.

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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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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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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 Data Safety Monitoring Boards

Using a single Data Safety Monitoring Board for an entire therapeutic program ensures continuity and offers cost savings and efficiency gains.

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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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