Long-term follow-up (LTFU) is a defining feature of oncology and cell and gene therapy (CGT) trials, where post-treatment monitoring often spans 2 to 15 years. These extended timelines allow regulators to assess long-term safety and efficacy from detecting delayed adverse...
Betsy Reid
Clinical Development
Navigating the New Era of Decentralized Clinical Trials
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...
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,...
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...