Partnering for Success—Performance Measurements for Sponsors, Contract Research Organizations, and Site Management Organizations

Despite the best efforts of the Food and Drug Administration (FDA), the pharmaceutical industry, and contract research organizations (CROs), the time associated with bringing drugs to market continues to rise. Much of the delay associated with drug development stems from the fact that investigative sites comprise a highly fragmented industry, with variable expertise and inconsistent quality. The consolidation of research sites through site management organizations (SMOs) has been promoted as the means to standardize and improve the quality of research services and accelerate clinical development. The benefits, to sites and sponsors, include quicker study start-up, faster patient enrollment, and reduced monitoring and management costs. The SMO market is in the midst of both rapid growth and consolidation, with resultant uncertainty concerning the skills and benefits of this research innovation. Sponsors are seeking SMOs which can facilitate the key resources of clinical trials, that is, sites and patients. Partnerships between sponsors, contract research organizations, and site management organizations can provide important competitive advantages in accelerating lead development times to exploit contract research resources. Effective program planning, proactive research strategies, and ongoing scientific and business collaboration are the components of a process leading to faster time to market. This review addresses the criteria and measures necessary to set expectations and drive performance in successful research partnerships.