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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Addressing Barriers to DEI in Clinical Research

Breaking down barriers to participation in clinical research has long been a challenge, affecting every…

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Making the Most of Site Training: Lessons from the Pandemic

The shift to virtual site training reveals innovative ways to maintain engagement and consistency, enhancing…

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The Power Of Patient Advocacy In Drug Development

Recently, we discussed the importance of connecting with advocacy groups in order to create more…

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The Rise of Gene Therapy: A New Era in Medicine

  Gene therapy is rapidly transforming from an experimental treatment into a cornerstone of modern…

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Q&A from Remote Monitoring: Study Compliance In A Changing World

In a recent webinar, Advarra experts Emily Eldh and Ben Shankle provided insights and information…

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Pitfalls of Chemistry, Manufacturing, and Controls in Investigational New Drug Preparation

Developing an investigational new drug (IND) application is a big milestone for organizations, especially small…

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Regulatory Fine Points: What Research Sites Need to Do for Part 11 Compliance

To maintain Part 11 compliance, research sites must validate electronic systems storing FDA-regulated records, safeguarding…

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How to Be Research Ready: Today and Beyond

Research readiness ensures that your organization can accept, activate, and adapt to new studies and…

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Building a Foundation for Regulatory Success in the Post-Pandemic Landscape

The past year has been one of the most challenging ever for those working in…

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Q&A: FDA Inspections of Clinical Investigators: Understanding the Process and What to Expect

In a recent webinar, Advarra experts Constance Cullity and Michele Russell-Einhorn presented FDA Inspections of…

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Phase I Oncology Clinical Trials

In a recent blog, we described the complexity and uniqueness of Phase I clinical trials,…

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Study Startup Success for BioPharma and MedTech: Engage a Research Compliance Partner

A key element to successful study startup is identifying efficiencies to help meet critical milestones.…

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