IRB Archives

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.