Transitioning Clinical Data Management from the 1980S to the 2010S: Strategies for Corporate Decision Making
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Drug Information Joumal, Vol. 35. pp. 713-719, 2001 Printed in the USA. All rights reserved.
TRANSITIONING CLINICAL DATA MANAGEMENT FROM THE 1980s TO THE 2010s: STRATEGIES FOR CORPORATE DECISION MAKING RONALDS. WAIFE,MPH President, Waife & Associates, Inc., Needham, Massachusetts
Clinical development executives realize that their processes must be enabled by technology and other process innovations in order to handle the capaciv, speed, and efticiency challenges of an increasingly competitive business environment. Technology companies are pushing for ever-more rapid iterations of generational change in software, systems, and information-handling, from improved versions of traditional clinical data management systems to electronic data capture, and on to electronic clinical trials and business intelligence. The business model for using and paying for these technologies is increasingly complex and confusing compared to the traditional sponsor/vendor relationship, with sponsors having the opportuniry to decide how much and what is kept inside or provided from outside services. This paper reviews these conditions and evaluates strategies that corporate executives can follow in selecting and implementing the technologies and business models that are right for their operations today and in the short-tern future. Managers must approach this complex matrix of information and options with a process for decision making, and understand the operational implications, costs, and benefits of each path. The paper covers the need to prepare the organization tactically ajler the strategy is selected, and the tasks required to implement new technologies and processes successfully. Key Words: Clinical data management; Information technology; Process improvement; Electronic data capture; Strategies for the future
INTRODUCTION: A FUNCTION IN TRANSITION WHILE THE WINDS OF change have been blowing through the pharmaceutical industry for many years, with areas such as basic research, discovery, manufacturing, and even sales undergoing radical changes in their processes, clinical development-and especially clinical data management-has changed much Reprint address: Ronald S. waife, WH,Resident, Waife & Associates, Inc., 62 Warren Street, Needham, MA 02492.
more slowly. Clinical data management went through important changes in the 1980s, introducing computer systems and paper handling methodologies that were fundamental improvements over the past. But these workflow and data processing models from the 1980s have continued essentially unchanged at most companies and contract research organizations (CROs) since that time. We now find ourselves starting a new decade and a new century, and most clinical data management organizations are in transition, finally reevaluating the processes that have become “traditional.” There are large dis-
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crepancies from company to company in how radically they are willing to change clinical data management in the short term, even as there is general unanimity that it must change, in some way. Som
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