Latest General Resources

IRB Review of Virtual Trial Technologies

Last month, James Riddle presented the webinar Accelerating the Recovery – IRB Review of Virtual Trial Technology. In a follow-up blog, he takes a deeper dive into the topic.

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Accelerating the Recovery – Design and IRB Review of Safety Monitoring Plans During COVID-19

How do remote visits and data collection impact participant monitoring? What techniques will satisfy the regulatory obligation to conduct safety and data monitoring in this new remote research world?

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Making a Case for HRPP Interim Staffing

Providing interim HRPP support can help your team fill in staffing gaps while staying on top of research and moving protocols forward.

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Good Manufacturing Practices: When Do They Apply?

Oftentimes, research teams struggle with knowing when to apply current Good Manufacturing Practice regulations. The FDA outlines expectations for the application of cGMP to investigational drugs.

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12 Items Auditors Look for When Reviewing an Investigator Site File

Maintaining complete, compliant documentation during a trial can be challenging. ISFs help ensure ICH E6 (R2) section 8 are met by checking the content of a variety of documents.

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Fireside Chat: The Future of Clinical Trials and Site Engagement

Fireside Chats, a new virtual series presented by Advarra, launches this month, bringing the research community together to discuss challenges and potential solutions.

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Q&A: The New Normal: Considerations for Restarting Research

In a recent webinar, Advarra IRB and research compliance experts discussed key areas to consider when ramping up research in the COVID-19 pandemic’s “new normal.”

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Q&A: Gene Therapy Research in the Age of COVID-19: Study Startup for Infectious Disease, Oncology, and Rare Disease Research

In Advarra’s inaugural virtual symposium, experts from industry and academia met to discuss the unique challenges gene therapy research poses for research sites, sponsors, CROs, and study participants.

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Bringing the Gene Therapy Conversation to You – Virtually

On June 3, members of the research community gathered virtually to discuss updates on hot topics and emerging issues in gene therapy.

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Safety Precautions for Laboratory Research With COVID-19 Specimens

Biosafety has surged to the spotlight due to the current COVID-19 global pandemic, motivating sites to conduct a risk assessment and develop a risk mitigation plan.

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