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
IRB
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
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
When Do Clinical Trials of mRNA Products Fall Under IBC Review
Discover how AI and analytics are transforming clinical trial operations, from study startup to accrual workflows, in this insightful whitepaper.
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
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
How Sponsors Can Use Adaptive and Platform Trial Models to Reduce Amendments and Accelerate Study Start-Up
Traditional clinical trial designs often delay progress due to rigid protocols and frequent amendments. Adaptive and platform trial models introduce flexibility and shared infrastructure, reducing startup delays, cutting costs, and enabling sponsors to conduct faster, more efficient research.
Enabling Oncology Site Success: Overcoming Administrative and Operational Barriers to Advance Cancer Research
In this webinar, leaders from cancer centers and biopharma companies will discuss the operational and institutional hurdles sites face and what can be done to address them. The panel will explore practical strategies to reduce burden, improve collaboration, and create a better experience for research staff and patients alike.
From Ethics to Evidence: Applying Real-World Data in Oncology Trials
Join experts from Johnson & Johnson Innovative Medicine, Bayer, The START Center for Cancer Care, and Advarra to discuss the ethical use of real-world data in clinical research.
Q&A with Advarra’s new Senior Vice President, FDA Regulatory Advisor, Jan Hewett
Clinical research drives medical progress. Advarra ensures participant safety and ethical standards through expert IRB oversight for life-changing therapies.