The clinical research triad: how can we ensure quality in out-sourced clinical trials?

The importance of quality within clinical trials cannot be underestimated. Built on the foundation of patient care where quality may simply be understood and expected, the business of conducting clinical trials must evolve to instill quality and ensure that quality is maintained. How that is accomplished within the drug development process is complicated by the relationship between the vendors--the sponsor, the contractor and the investigative site. This article will discuss the dynamics of the drug development triad from the perspective of the authors. Who are the players and what is quality from each of their perspectives? Communication among all parties is essential in order to ensure that quality is maintained. Unfortunately, even with optimal communication, if expectations and goals are not clearly defined, the results may be unsatisfactory. Vision and values of each player contributes to the success of the relationship and the quality of the service.