The Bone and Muscle Safety Gap That GLP-1 Megastudies Weren’t Designed to Fill
Lilly and Novo have already won the weight-loss efficacy war. The next drug approval battle is being fought on...
Korea’s Integrated Approach to Clinical Trial Planning: A New Model for Global Sponsors
The sponsor team had expected a slow start in Europe, but they weren’t prepared for how fragmented the process...
ICH E6(R3) Raises the Bar on Imaging in Clinical Trials—Are You Ready?
When the FDA inspector arrived, no one expected imaging to be the issue. The scans had been read. The...
Why FDA’s Draft 510(k) Guidance is Forcing Sponsors to Rethink Device Submissions
The device team thought they were following the playbook. They chose a predicate that had been cleared two decades...
How Sponsors Can Win or Lose in the 510(k) Strategy Pathway
The start-up team was confident. Their Class II device had promising bench data, strong engineering, and investors eager for...
FDA and EMA Push for Predicting Protocol Deviations. How Psychology Can Help
The site team was blindsided. The patient met every inclusion and exclusion criterion, showed no red flags, and even...
Behavioral Science: The Untapped Asset in Obesity Trial Strategy
The global obesity epidemic has shifted from a public health issue to a fiercely competitive pharmaceutical frontier. With GLP-1...
Understanding the FDA’s Draft Guidance on Protocol Deviations in Clinical Investigations
The U.S. Food and Drug Administration (FDA) has released a draft guidance document titled Protocol Deviations for Clinical Investigations of...
Pragmatic Trials? All Talk, No Real Progress
Pragmatic clinical trials have become one of the industry’s favorite buzzwords, but where’s the real progress? Every year, the...
The Emergence of Superintelligence in Healthcare, Biotech, and Clinical Trials
The journey toward superintelligence unlocks extraordinary capabilities poised to revolutionize medicine and healthcare. These systems can process vast amounts...