04.11.26 -- Clinical Leader Best Of March

Former FDA Commissioner Dr. Robert Califf has been blunt about what’s wrong with informed consent in clinical trials. In this article, we offer a high-level look at his three-part Substack series, exploring how consent became more about legal protection than patient understanding — and what needs to change.

AI is quietly transforming clinical trials at the site level, boosting efficiency while creating hidden risks for patient data, protocols, and sponsoring intellectual property.

Regulators want one thing during inspections — to see how the data flows. Just In Time GCP's Donna Dorozinsky explores the importance of data oversight and where sponsors sometimes go wrong.

Empower your teams to move beyond static reports by leveraging R Shiny to transform data into interactive, real-time insights that drive smarter, faster decisions.

From balancing treatment ratios and managing eligibility to accommodating site-specific readiness and protocol amendments, a well-designed IRT system enables seamless transitions.

Before you dive into clinical trials, ask yourself: Is my company operationally ready to handle the complexity? Learn about key upgrades that can help you streamline operations and reduce risk.