“Google It.” Those two words encapsulate our modern approach to seeking information. And when it comes to research, the first instinct a potential participant may have is to jump online to find more details. But what happens if a suitable study lacks an online presence?…
In clinical trials, time is currency. Every missed day, milestone, or patient recruitment opportunity comes at a price, sometimes in the millions. While most sponsors focus on patient recruitment and data capture, the foundational role of timely equipment procurement is often overlooked. With clinical trial…
Is outsourcing clinical trial services a smart strategy or a risky gamble? The answer depends on how you approach it. This topic was particularly highlighted for me during the Outsourcing in Clinical Trials East Coast conference, which took place at the Valley Forge Casino Resort…
Diversity in clinical trials is now mandated by law. While the importance of study diversity has long been emphasized, this marks the first time it has been codified into law under the Food and Drug Omnibus Reform Act of 2022 (FDORA).1 Through diversity action plans,…
In January 2024, I wrote about the FDA’s then-pending clinical research diversity requirements. Since that time, the regulatory landscape has shifted dramatically. This update outlines the most recent developments—including federal mandates under the Food and Drug Omnibus Reform Act (FDORA), the status of the FDA…