Unlocking Unstructured Data with AI for Optimized Protocol Development
Unlocking Unstructured Data with AI for Optimized Protocol Development In this podcast episode, Mike Eckrote, Senior Vice President of Strategic
sponsors
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
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
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
Federal Public Policy Briefing: Understanding 21 CFR 50.54: When FDA-Regulated Pediatric Research Requires Federal Review
Federal Public Policy Briefing: Understanding 21 CFR 50.54: When FDA-Regulated Pediatric Research Requires Federal Review Research involving children that poses
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
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
Clinical Trial Budget Negotiations: A View From Each Side
Budget negotiation success hinges on clear communication and early resource sharing, helping sites and sponsors align expectations and avoid costly delays.
Good Manufacturing Practices: When Do They Apply?
Navigating cGMP application in investigational drugs can be complex. Learn how FDA guidelines help clinical teams maintain safety and quality from early trials to commercialization.