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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Key Considerations for Regulatory Compliant Document Storage

Compliant document storage in clinical trials demands robust systems for security, accessibility, and retention to…

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Informed Consent: When, Why, and How It’s Obtained

Informed consent isn’t just a formality—it’s an evolving process that safeguards participant autonomy and enhances…

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Q&A: Institutional Responsibilities Under a Federalwide Assurance

In a recent webinar, Advarra regulatory experts presented on the topic titled Institutional Responsibilities Under…

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Understanding the Complexity and Uniqueness of Phase I Trials

In clinical research, working with organizations that understand the ins and outs of the phase…

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Q&A – Regulatory Fine Points: Exploring 21 CFR Part 11 Validation

In a recent webinar, James Riddle, Shannon Roznoski, and Stuart Cotter of Advarra presented Regulatory Fine…

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Utilizing eRegulatory Integrations to Expedite Regulatory Workflows

The processes necessary to support regulatory compliance require valuable time and resources within a clinical research…

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mRNA and Its Role in Clinical Research

In the race to address the COVID-19 pandemic, researchers have worked tirelessly the past year…

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Expanding Our Global Consulting Expertise to Solve Mission-Critical Issues

Elevating our consulting capabilities to accelerate clinical research and bring therapies to market sooner. YourEncore,…

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Does Warp Speed Vaccine Development and Testing Compromise Safety?

A common trope in sci-fi movies involves concerns about potentially smashing into uncharted objects while…

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Top 10 Educational Resources of 2020

It’s safe to say 2020 has been more unpredictable than anyone could imagine. Through these unprecedented…

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New FDA Certificate of Confidentiality Guidance: What Does it Mean for You?

FDA has recently issued guidance relating to changes for Certificates of Confidentiality (CoCs) brought about…

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What is the ROI of eLearning?

On-demand eLearning maximizes ROI by cutting classroom costs and offering accessible, effective training that aligns…

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