Knowledge Innovation and Clinical Operational Excellence

Abstract

With the emergence of the knowledge economy, competitive advantage in the pharmaceutical industry is dependent on effective handling of data, information, and knowledge. For Novo Nordisk, venturing from clinical trials in nona-cute indications to those in acute critical care highlighted the problems associated with generating overwhelming amounts of data in the latter setting. Conventional methods of conducting clinical trials were not sufficient to cope with the complexity of acute critical care, so the New Way of Working was developed. The main differences of this approach are: use of a modifiable clinical operational plan that allows for continual evaluation and problem solving; parallel processing to reduce overall time from trial start to results; and an integrative team approach to personnel structure. This model has demonstrated marked advantages over conventional processes in our NovoSeven clinical trials, such as improved data collection and flow, enhanced problem identification and correction, reduced study duration, and more effective patient management. Hence, pharmaceutical companies can attain competitive advantage through clinical innovation by optimizing knowledge exchange within an environment of clinical operational excellence.