From Local Information Technology Support to a Global Information Management Organization in Pharmaceutical Research and

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0092-8615/2001 Copyright 0 2001 Drug Information Association Inc.

FROM LOCAL INFORMATION TECHNOLOGY SUPPORT TO A GLOBAL INFORMATION MANAGEMENT ORGANIZATION IN PHARMACEUTICAL RESEARCH AND DEVELOPMENT MARTINWILHELM Dr. GBhring & Partner AG, Dilsseldorf, Germany

This article discusses the design of an information management organization based on a real-life reengineering project. The organization was developed out of a worldwide project team and established parallel to the system roll-out. Three factors were most important for success: 1. excellent system documentation deduced from well-developed information engineering architectures, 2. careful integration of the information management concept into the user community, and 3. the preparation of clear and comprehensive business processes and roles of the information management organization. The organizational model was created as a corporate matrix comprising roles and functions on three hierarchical levels. The responsibilities for system redesign and change management are centralized and unique. Major technical support was limited to server locations and intense user support was made available in every clinical unit worldwide. Furthel; the model integrates research and development (R&D) and computer center services worldwide based on company internal service level agreements. Key Words: Information management; R&D; Change management; Reengineering; User

support; Organizational development

INTRODUCTION THE PHARMACEUTICAL INDUSTRY shows a remarkable particularity with respect to its information management. Due to the highly specialized nature of the information systems and the particular requirements of the R&D workflow there exists a variety of specialized departments or groups which are responsible for application maintenance. In many cases even each R&D suborganization such as preclinics, clinical development, pharmacological development, and so forth has its own information technology (IT) Reprint address: Martin Wilhelrn, Dr. GShring & Partner AG, Hauptstrasse 43, D-40597 Diisseldorf, Germany.

group at headquarters and major affiliate companies. Such an organization almost automatically leads to insular IT optimization, budget and resource intransparency, and hampering of a productive and fast global information flow. When global information systems for document management, patient data management, or study tracking are implemented, local heterogeneity results in tremendous extra cost and effort. Today, a striking effect can be observed in pharmaceutical R&D: despite a dramatic increase in investment in current technology the gross productivity of drug development does not increase proportionally. In many cases, a close look at the global information policy reveals the reason. The basic technol17

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Martin Wilhelm

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ogy and the R&D business processes are organized decentrally and optimized locally; no global acting information management organization is established. While the