An overview of the FDA’s latest guidelines and requirements for DCTs, highlighting key aspects such as the integration of digital health technologies, remote monitoring, and the adherence to Good Clinical Practice (GCP) principles, as well as ensuring innovative trials maintain the highest standards of safety, efficacy, and data integrity.
Discussion of the FDA’s collaborative efforts with other regulatory bodies, promoting harmonized standards and facilitating global acceptance of DCT methodologies.
Adhering to the FDA’s comprehensive regulatory requirements so sponsors can navigate the complexities of DCTs and contribute to the evolution of clinical trials and the accelerated development of innovative medical treatments
