Compliance challenges in clinical research organizations: A USFDA inspection retrospective

• Main Authors: Sudheer Kumar (Author), Raju Kamaraj (Author)
• Formato: Livro
• Publicado em: GarVal Editorial Ltda., 2024-01-01T00:00:00Z.
• Assuntos: article
• Acesso em linha: Connect to this object online.

Context: Clinical research plays a vital role in advancing medical knowledge and improving patient care. As regulatory bodies strive to ensure the integrity and safety of clinical trials, the US Food and Drug Administration (USFDA) conducts inspections to evaluate compliance with established regulat...