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Latest Posts by Advarra

Clinical Trial Governance: What It Is and Why It Matters 

Clinical trial governance is the framework that guides ethical, compliant, and efficient clinical research. It establishes the...

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What Is the Difference Between an SAE, AE, and UADE in Clinical Trials? 

Adverse events (AEs) are untoward medical occurrences in participants receiving a study intervention, regardless of...

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Q&A with Advarra’s Senior Coordinator of Client Services Rachel Garrett 

Rachel Garrett’s career in clinical research has come full circle. After starting her journey at...

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What Is the Difference Between Monitoring and Auditing in Clinical Trials And Why Do They Matter for Inspection Readiness?

Clinical trial monitoring (CTM) and auditing are both essential quality management activities, but they serve...

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Why Do Clinical Trial Startup Delays Still Happen Despite More Technology? 

Clinical trial study startup has become increasingly technology-enabled, yet sponsors, contract research organizations (CROs), and...

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Updated IRB Handbook Available

Advarra’s IRB Handbook Advarra has updated its Institutional Review Board (IRB) Handbook for Investigators, Institutions,...

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Improving Clinical Trial Site Collaboration with Connected Study Startup Workflows 

Clinical trial study startup requires constant coordination across sponsors, contract research organizations (CROs), research sites,...

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21 CFR Part 11 and Good Clinical Practice Requirements Explained 

Clinical research increasingly depends on electronic systems to support core trial documentation, data handling, and...

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Q&A with Advarra’s Client Services Team Lead Kyle Naylor 

Kyle Naylor didn’t set out to work in the IRB world—but once he found it, he never...

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Sponsor’s Guide to IRB Approval (Part VI): After IRB Approval: Compliance, Multi-Site Oversight, and Turning Review into a Strategic Advantage 

IRB approval is a critical milestone in clinical research, but it isn’t the end of the oversight...

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Q&A with Advarra’s Manager of Ongoing Review MaryJo Carter 

MaryJo Carter has spent more than nine years at Advarra, growing alongside the organization and helping shape...

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Ensuring Operational Feasibility in Next-Generation Oncology Trials

Our webinar discusses key near-term trends and regulations and investigate persistent challenges frequently throwing even...

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