Decentralized Clinical Trials (DCTs) are not a novel concept but have gained prominence with advancements in digital technology and the increasing need for patient-centric approaches. The recent release of the FDA’s final guidance on DCTs in September 2024 marks a significant milestone in this journey, providing much-needed clarity and support for sponsors looking to incorporate…
Decentralized clinical trials (DCTs) have emerged as a promising solution to address the unique challenges of pediatric rare disease research. In this blog, we discuss the intricate landscape of conducting clinical research in pediatric rare diseases, identify the unique challenges, discuss the potential of decentralized trial strategies, and underscore relevant risks and considerations. Navigating the…
Infant formula is an essential food product that serves as the sole source of nutrition for many babies in North America and Europe during their first year of life, supporting health, growth, and development.1,2 More than a year since the shutdown of the largest infant formula plant in the US in February 2022, the country…
