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 […]
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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
Does mRNA Require IBC Review? How the NIH Guidelines Apply to Clinical Trials
Let me start with a question I get more and more frequently from research sites as mRNA continues to expand
Sponsor’s Guide to IRB Approval (Part III): Building an IRB-Ready Informed Consent
For sponsors, informed consent is one of the most visible signals of study quality during IRB review. It’s also a
A More Connected Approach to Clinical Trials: Reducing Friction from Study Design Through Conduct
Clinical trials are complex. That’s expected, given accelerated advancements in science and technology. But when that complexity creates friction in
Sponsor’s Guide to IRB Approval (Part II): How to Draft a Clinical Trial Protocol That Stands Up to IRB Scrutiny
A strong clinical trial protocol does more than describe how a study will run. It also helps reviewers understand why
Gene Therapy Is Seen as the Next Big Biologic in Ophthalmology
Over the last 15 to 20 years, monoclonal antibody-based treatments, such as those targeting vascular endothelial growth factor (anti-VEGF), have
Sponsor’s Guide to IRB Approval: What Every Sponsor Needs to Know Before Submitting a Study
Introducing the “‘Sponsor’s Guide to IRB Approval’“ Institutional review board (IRB) approval protects the rights, safety, and welfare of research participants, and