The rapid development of Cuba's pharmaceutical industry in the 1990s created a need for structures to ensure clinical evaluation of products before their introduction into medical practice and subsequent marketing. One of the centers founded for this purpose was the National Clinical Trials Coordinating Center. This paper summarizes the factors that motivated the creation of the Center and presents a brief history of its organizational development over the last 17 years. It also describes the main components of the system for designing and conducting clinical trials, and the most significant contributions of each toward achieving the Center's objectives.