Knowledge Innovation and Clinical Operational Excellence
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Knowledge Innovation and Clinical Operational Excellence Lirelotte Hyveled, MSc, MSc (Pharw) V P Clinical Operations, Trial Management, Novo Nordisk A / S , Bagsvcprd. Denmark Pramod Karpur, MS Senior fnfomation Logistics Manager NovoSeven Key Projects, Clinical Operations. Novo Nordisk A / S , Bagsvcprd. Denmark Henrik Nakskov, MSc (Chew), HD (SCM) Clinical lnformatics Manager, NovoSeven Key Projects, Clinical Operations. Novo Nordisk A/S. Bagsvcerd, Denmark
Key Words Knowledge; Innovation; Clinical trials; Data management Correspondence Address Liselotte Hyveled. Trial Management, Novo Nordisk A/S, Krogshejvej 51, 9F 1.35 DK-2880 Bagsvcerd, Denmark (email: Ihy @novonordisk.com).
With the emergence of the knowledge economy, competitive advantage in the pharmaceutical industry is dependent on efective 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. Conventionalmethods of conducting clinical trials were not suficient to cope with the complexity of acute critical care, so the New Way of Worln'ngwas developed. The main diferences of this approach are: use of a modijiable clinical opemtionalplan that allows for contin-
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-
ual evaluation and problem solving; pamllel processing to reduce overall timefrom 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 cdlection and flow enhanced problem identification and correction, reduced study dumtion, and more eflc&ve patient management. Hence, pharmaceutical companies can attain competitive advantage through clinical innovation by optimizing knowledge exchange within an environment of clinical opemtional excellence.
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