Drug Information Journal - March 2009 - (Page 159) MEDICAL INFORMATION 159 Knowledge Innovation and Clinical Operational Excellence Liselotte Hyveled, MSc, MSc (Pharm) VP Clinical Operations, Trial Management, Novo Nordisk A/S, Bagsværd, Denmark Pramod Karpur, MS Senior Information Logistics Manager, NovoSeven Key Projects, Clinical Operations, Novo Nordisk A/S, Bagsværd, Denmark Henrik Nakskov, MSc (Chem), HD (SCM) Clinical Informatics Manager, NovoSeven Key Projects, Clinical Operations, Novo Nordisk A/S, Bagsværd, Denmark 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 nonacute 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 contin- ual 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. Key Words Knowledge; Innovation; Clinical trials; Data management Correspondence Address Liselotte Hyveled, Trial Management, Novo Nordisk A/S, Krogshøjvej 51, 9F 1.35 DK-2880 Bagsværd, Denmark (email: lhy@novonordisk.com). INTRODUCTION Over the last two decades, increased information flow has had a major impact on business development and management. Significant advances in information and communication technology led to the information age of the 1980s when the movement of information became faster than physical movement. Acquiring and disseminating the limited information available during that time generated a significant competitive advantage for businesses, with companies that focused on providing the underlying technology for information distribution (eg, Microsoft) becoming phenomenally successful. As a consequence of such technological developments and the ensuing abundance of accessible information, information and knowledge have become the key factors in producing economic benefits. Hence, it is widely accepted that the present global economy can be described as a knowledge economy, a phrase first used by management expert Peter Drucker to describe how value is created by applying knowledge—the primary means of production—in the work environment (1). With the emergence of the knowledge econo- my, organizations need to adapt to the high frequency of change and focus on the exchange of data, information, and knowledge (2). In contrast to most resources that diminish when used, knowledge is renewable and in fact increases in value through sharing and application. Hence, knowledge and how it is exploited determine a company’s uniqueness such that maintaining a competitive advantage is now largely dependent on the process of knowledge innovation. Knowledge is now the most valuable resource for creating economic wealth, while converting knowledge into marketable products or services is the key to successful innovation. In addition, collaboration rather than competition between companies, with pooling of knowledge and intellectual assets, is important for success in the knowledge economy. The pharmaceutical industry is one of the industries most closely associated with the knowledge economy, and pharmaceutical companies need to optimize their ability to handle knowledge in order to survive an increasingly competitive climate. The amount of data collected during clinical trials has rapidly escalated over the last 20 years, leading to the troubling scenario of trial personnel being overwhelmed by the extraordinary volume of information availSubmitted for publication: July 26, 2007 Accepted for publication: September 9, 2008 Drug Information Journal, Vol. 43, pp. 159–170, 2009 • 0092-8615/2009 Printed in the USA. All rights reserved. Copyright © 2009 Drug Information Association, Inc.
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