For Sponsors accustomed to the structured world of clinical trials, stepping into expanded access can feel deceptively familiar. Both involve investigational medicinal products. Both require regulatory engagement. Both carry inherent risks while the product’s safety and efficacy are [...]

The primary purpose of any Expanded Access (EAP) or Post-Trial Access (PTA) Program is to help patients with serious or life-threatening conditions gain access to potentially life-saving therapies when no suitable treatment options are available. [...]

Clinical trials are moving out of hospitals and research centers and into people's living rooms. Home visits, remote assessments, and community-based care are no longer a workaround for hard-to-reach patients. They are becoming a core [...]