Transitioning Clinical Data Management from the 1980s to the 2010s: Strategies for Corporate Decision Making

Clinical development executives realize that their processes must be enabled by technology and other process innovations in order to handle the capacity, speed, and efficiency challenges of an increasingly competitive business environment. Technology companies are pushing for ever-more rapid iterations of generational change in software, systems, and information-handling, from improved versions of traditional clinical data management systems to electronic data capture, and on to electronic clinical trials and business intelligence. The business model for using and paying for these technologies is increasingly complex and confusing compared to the traditional sponsor/vendor relationship, with sponsors having the opportunity to decide how much and what is kept inside or provided from outside services.

This paper reviews these conditions and evaluates strategies that corporate executives can follow in selecting and implementing the technologies and business models that are right for their operations today and in the short-term future. Managers must approach this complex matrix of information and options with a process for decision making, and understand the operational implications, costs, and benefits of each path. The paper covers the need to prepare the organization tactically after the strategy is selected, and the tasks required to implement new technologies and processes successfully.