Clinical trial monitoring (CTM) and auditing are both essential quality management activities, but they serve distinct purposes throughout the research
Clinical research increasingly depends on electronic systems to support core trial documentation, data handling, and regulated workflows. That shift has
Unlocking Unstructured Data with AI for Optimized Protocol Development In this podcast episode, Mike Eckrote, Senior Vice President of Strategic
How operational insight, performance data, and patient access signals can strengthen clinical trial site decisions Choosing the right sites can
IRB approval is a critical milestone in clinical research, but it isn’t the end of the oversight process. For sponsors, approval marks
Institutional review board (IRB) approval is a critical milestone in clinical research, but it can also become a source of
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 Research involving children that poses
Let me start with a question I get more and more frequently from research sites as mRNA continues to expand
For sponsors, informed consent is one of the most visible signals of study quality during IRB review. It’s also a
A strong clinical trial protocol does more than describe how a study will run. It also helps reviewers understand why
Introducing the ‘Sponsor’s Guide to IRB Approval’ Institutional review board (IRB) approval protects the rights, safety, and welfare of research participants, and
