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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An Evolving Regulatory Environment for Rare and Orphan Diseases
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An Evolving Regulatory Environment for Rare and Orphan Diseases

Rare diseases affect fewer than 200,000 people each, totaling around 30 million in the U.S.…

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Enhancing Research Conduct Using eConsent
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Enhancing Research Conduct Using eConsent

eConsent in clinical trials enhances participant understanding and flexibility but requires careful planning, regulatory compliance,…

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5 Questions to Ask Your Sponsor for DCT Implementation

The pandemic proved decentralized clinical trials (DCTs) can reduce patient burden while delivering quality data…

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Clean Bench vs Biosafety Cabinet: What’s the Difference?

Institutional biosafety committees (IBCs) frequently receive questions about the proper type of hood for use…

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ich q12 guidance
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Regulatory Considerations for Pharmaceutical Product Lifecycle Management

As a pharmaceutical product makes its way through the lifecycle, there are often Food and…

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CBD Research: A Dive into the Regulations of Cannabis Research

Cannabis use has become widespread. As such, we are seeing an uptick in research examining…

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Q&A: The IND Journey Phase I – Navigating Success

Advarra experts Sharon Ayd and Leslie Paul answer questions from their webinar, The IND Journey…

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Short Form Consents and the Unexpected Non-English Speaking Participant

Short form consents provide a crucial bridge for unexpected non-English speaking participants, ensuring informed consent…

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Beginner’s Guide to eTMF, eISF, and Clinical Research Documents
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Beginner’s Guide to eTMF, eISF, and Regulatory Research Documents

Efficient document systems like eTMF and eISF enhance compliance and streamline document management, helping sites…

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Return of Research Results to Study Participants
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Return of Research Results to Study Participants

Individuals invest a great deal to participate in clinical research, undertaking risks and burdens, while…

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two internet windows being connected by Advarra's partner program
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Expanding the Ecosystem to Better Serve You

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Common Pitfalls in Preparing an IND Application

As a drug successfully makes it through the development process, sponsors will inevitably need to…

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