How Amendment Intelligence Helps Reduce Avoidable Protocol Revisions
Clinical development teams can use operational and institutional review board (IRB) data to identify protocol-design risks before those risks trigger […]
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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, and institutional review boards (IRBs).
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 regulated workflows. That shift has
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 looked back. Now a team lead supporting
A Practical Checklist for Building Confidence in Site Selection
How operational insight, performance data, and patient access signals can strengthen clinical trial site decisions Choosing the right sites can
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 process. For sponsors, approval marks
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 how teams show up for
Sponsor’s Guide to IRB Approval (Part V): How to Speed Up IRB Approvals
Institutional review board (IRB) approval is a critical milestone in clinical research, but it can also become a source of
Data Safety Monitoring Boards (DSMBs) in the Era of AI and Adaptive Clinical Trials
Balancing innovation, statistical rigor, and independent oversight in increasingly complex clinical trials Clinical trials are no longer static. Over the
Why Should Local IRBs and HRPPs Collaborate with External IRBs?
Multisite research and clinical trials increasingly rely on a single IRB (sIRB) for review. This increase reflects federal mandates, sponsor expectations, and the operational realities of modern multisite or cooperative research. For institutions with a local
Sponsor’s Guide to IRB Approval (Part IV): Preparing IRB Documents That Prevent Delays
A strong protocol and well-drafted consent form are essential, but they are not enough on their own to support a
Q&A with Advarra’s Associate Director of Client Success Evan Sander
Evan Sander knows firsthand that clinical research is never just about processes or paperwork—it’s about people. As associate director of