Drug developers have long relied on animal studies to generate critical nonclinical evidence before testing a therapy in humans. But as our understanding of human biology and our ability to model it become more sophisticated, the role of animal testing...
The right clinical outsourcing strategy starts with the needs of the program—not a predefined delivery model. Use this checklist to evaluate the priorities that should shape your approach, determine what should remain internal versus externally supported, and align your desired...
Patient centricity is often most visible at the point of trial participation—through recruitment strategies, patient communications, travel support, and other services designed to facilitate engagement. But by the time these elements are introduced, many of the decisions that shape the patient experience...
Protocol amendments can materially alter the trajectory of a clinical development program—delaying critical milestones, increasing costs, disrupting recruitment, and creating additional burden for sites and patients. While some amendments are necessary, many can be traced to protocol design decisions that were not...
This survey report explores insights from 150 life science leaders about protocol development and strategies for minimizing the risk of amendments. Protocol amendments can increase costs, disrupt recruitment, and delay clinical development. But they aren’t always inevitable. In fact, 95%...