Advarra Blog

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

While central IRB review has been an option for decades, the practice has recently become required for many organizations who fund or support clinical research. The sIRB movement seeks to streamline a critical research process and reduce administrative burdens while maintaining appropriate participant protections.

How Sponsors and Sites Work Together to Improve Protocol Compliance

Sites and sponsors can adopt strategies to reduce quality issues and avoid FDA warning letters…

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Addressing Industry Challenges: Staff Turnover

Staff turnover in clinical research impacts trial quality and timelines. Addressing this requires focus on…

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Our OnCore CTMS Vision: Building a Foundation for Success

OnCore’s future vision focuses on cloud-hosted solutions, cross-platform reporting, and SSO, enhancing efficiency and user…

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Unpacking The Role of a Right-Sized QMS in Study Startup

The study startup process involves a multitude of tasks and activities multiple teams coordinate to…

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A Phased Approach to QMS

A phased approach to quality management systems (QMS) ensures quality is embedded at every stage,…

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Thinking About the Box: Considerations for Transport of Investigational Products

Ensuring the safe and secure transport of investigational products (IP) is a core part of…

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Clinical Trial Startup: Insights from the Industry

The clinical trial startup process has seen significant shifts over the past five years: growth…

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The Role of Financial Management and GAAP in Clinical Research

Research sites play a pivotal role in clinical trials, responsible for participant recruitment, data collection,…

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Navigating CAPA in Clinical Development: Ensuring Compliance and Quality Assurance

When it comes to clinical development, precision, compliance, and quality assurance are paramount. Like any…

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Enhancing Research Ethics: Understanding HRPP Staffing and the sIRB Mandate

HRPP staffing is essential for maintaining research ethics, even with sIRB mandates streamlining review processes…

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What is a Data Monitoring Committee?

DMCs play a vital role in clinical trials by independently reviewing interim data for safety…

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GxP Best Practices for Safer, Smarter, Faster Clinical Research

GxP guidelines ensure clinical research meets rigorous standards for safety, quality, and compliance, supporting the…

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