Project Management in Pharmaceutical Biometry and Data Management: Conception, Implementation, and Operations
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Drug Information Journal. Vol. 32, pp. 221-228, 1998 Printed in the USA. All rights reserved.
PROJECT MANAGEMENT IN PHARMACEUTICAL BIOMETRY AND DATA MANAGEMENT CONCEPTION, IMPLEMENTATION, AND OPERATIONS MARTINWILHELM,PHD Dr. Gohring & Partner GmbH, Schlltzenhofstr, Germany
Biostatistics and data management are becoming increasingly complex. Patient numbers per study grow large6 authority requirements increase, preclinical activities need increased support, and new technologies need attention and effort. On the other hand, reengineering and improvement programs aimed at cutting costs and accelerating the research and development (R&D)processes are started. In parallel, the number of staff as well as the desired time frame for projects is reduced. To cope with that situation, an attempt is made to increase productivity through new computer technology and organizational measures such as standardization and resource or workflow management. Professional project management provides the instruments to achieve the desired productivity, Once the decision is made to implement project management, special attention should be focused on the selection and education of the project managers, a precise definition of tasks and desired results, and careful implementation in the interdisciplinary R&D environment. This article will outline the respective steps involved and will discuss examples for effective operations. Key Words: Data management; Project management; Effective organization; Resource management; Business process reengineering
RATIONALE EVEN THOUGH THERE are many examples where project management (PM) has proven its power of rational and economic resource utilization and and just-in-time project steering (for example, in the construction or process industry), its effectiveness is frequently disputed when applied to complex R&D processes. Many project management
Presented at the DIA 6th Annual Workshop on “Clinical Data Management,” November 4-45. 1996, London, United Kingdom. Reprint address: Dr. Martin Wilhelm, Dr. Gohring & Partner GmbH, Hauptstr. 43, D-40597 DUsseldorf, Germany.
units appear to be reactive administrators rather than proactive management instruments. If one takes a closer look at the ineffective ones it quickly appears that they lack the power to produce good performance a n d or are working on cumbersome, complicated corporate processes that nobody is willing to change. Biometry and data management today have to handle increasing complexity and diversity whereas staff is constantly reduced and the desired time frame for a clinical program is narrowed. In order to handle this situation, an attempt is made to increase productivity by implementation of state-of-theart technology. This technology provides a high degree of information integration and
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is able to satisfy the information demand of different corporate units (eg, marketing, medical services, drug safety, etc.) out o
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