Advarra Blog

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Ways to Streamline Informed Consent Process in Clinical Trial Startup

Optimizing the informed consent process is critical for accelerating clinical trial startup while maintaining compliance and participant understanding. This article explores key strategies for streamlining informed consent, including leveraging electronic consent (eConsent) solutions, standardizing templates, and improving collaboration between sponsors, sites, and IRBs. By implementing these best practices, research teams can enhance efficiency, reduce delays, and improve the participant experience in clinical trials.

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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 help clinical research meet rigorous standards for safety, quality, and compliance, supporting the…

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Beginner’s Guide to Human Research Protection Programs

Human research protection programs (HRPPs) play a critical role in protecting the rights, safety, and…

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

As research institutions are designing studies and recruiting participants for them, they must maintain compliance…

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

Single IRB (sIRB) review streamlines oversight for multisite trials, reducing administrative burdens while ensuring participant…

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Public Perceptions of Clinical Trials: A Comprehensive Survey

The clinical research industry is only becoming more complex and competitive as organizations are inundated…

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Operation Warp Speed for Rare Diseases: Expected Boom in Drug Development and Approval

Rapid growth in gene therapy is expected to receive additional support as the Food and…

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How Centralized IBC Review Can Benefit Gene Therapy Research

Gene therapy research is at the forefront of a coming boom in the clinical setting.…

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Understanding Various Site Use Cases for eSource and EDC

Sites can improve data capture, management, and compliance using a site-centric eSource or EDC platform,…

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Device Risk Determinations for IVD Research

Clinical trials involving investigational in vitro diagnostic (IVD) devices are subject to the Food and…

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Successful OnCore Implementation: Lessons from Blended Learning and Workforce Training

Implementing OnCore with a phased and blended learning approach at a large institution showed how…

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