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 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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Interim Staffing: Reinvigorating Your Human Research Protections Program

Interim staffing offers HRPPs specialized expertise, fresh perspectives, and support for accreditation and structural improvements…

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The Value of Continuity: Program-level Data Safety Monitoring Boards

In the realm of pharmaceutical development, ensuring the safety and efficacy of new treatments is…

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Understanding FDA’s 2024 Draft Guidance on DMCs

The FDA's 2024 draft guidance emphasizes the critical role of independent DMCs in clinical trials,…

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Reporting to the IRB: Unanticipated Device Effects in Medical Device Studies

In this blog, we’ll take a look at what the regulations do and do not…

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Reporting to the IRB: Investigator Noncompliance

We often get questions about exactly what events should be reported to the IRB. We…

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SAE Reporting and the IRB: Adverse Events in Drug Studies

Assessing and reporting adverse events (AEs) in clinical trials is critical to ensuring the study…

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Checklist to Reduce Burden on Sites and Patients

Every site is different. Learn how to meet their unique needs and make workflows and…

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Enhancing User Experience, Security, and Compliance with Single Sign-on

Every day, clinical research organizations work to deliver a seamless user experience for their staff,…

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IRB Review of Changes to Previously Approved Research

During the course of study conduct, most research involving human participants will require some form…

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Clinical Trial Efficiency: Top Risk Indicators and Solutions for Site Performance

Sponsor and contract research organization (CRO) team members such as clinical research associates (CRAs), study…

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