Advarra Launches Study Design Solution, Powered by Braid, to Improve Operational Efficiency in Clinical Trials — Read the Press Release

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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Budgeting for IRB Review: A Guide for HRPP Leadership

At institutional research programs around the U.S., there exists a pervasive myth: internal institutional review…

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Understanding the Impact of the New EU Artificial Intelligence Act on Clinical Research

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention.…

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Good Manufacturing Practices: When Do They Apply?

Navigating cGMP application in investigational drugs can be complex. Learn how FDA guidelines help clinical…

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Developing a Data-driven Feasibility Process

Clinical research is complex and resource-intensive, and to understand just how far an organization’s resources…

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The Regulatory Binder Checklist For Clinical Trial Sites

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating…

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The Importance of Hazard Communications in Clinical Trials Involving Genetic Engineering

Recombinant DNA technologies and genetically modified biological agents are being adapted for a wide scope…

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Navigating Local Considerations When Developing sIRB Reliance Policies

Implementing an sIRB process requires addressing unique local considerations, from consent requirements to cultural nuances,…

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GxP Audits Guide for Successful Clinical Trials

A robust GxP audit program enhances regulatory compliance by ensuring quality and consistency across investigator…

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Impact of sIRB Mandates on Study Teams

As sIRB mandates reshape the clinical trial landscape, study teams must navigate unique challenges while…

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Strategic Training: Navigating Organizational Challenges

Training is crucial for changing employee behavior, but not every issue requires it. Identifying when…

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Key Items Auditors Look for When Reviewing an Investigator Site File

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial…

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Planning for Complex Change at Your Organization

The only constant in clinical research is change. Researchers are always innovating, making it a…

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