Global Data Management: A Winning Approach to Clinical Data Processing
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GLOBAL DATA MANAGEMENT: A WINNING APPROACH TO CLINICAL DATA PROCESSING MONICAPIMAZZONI Data Scientist, Data Management Unit, Medical Data Sciences Department, Glaxo Wellcome S.p.A., Verona, Italy
In these days of company mergers, downsizing, greater external competitive forces, and pressure to use internal resources more efficiently, many pharmaceutical companies are approaching their business in global terms. The meaning of globalization among companies differs, however; and success is dependent on many factors. One of these factors, the efficient management of clinical data, is increasingly important. It is one of the keys to improving data quality, and thus, reducing the time to market. The globalization of the clinical data management operation requires the development of an integrated database system, the implementation of common working procedures, and the involvement of people from different countries with various cultural backgrounds. This paper covers the impact of and problems and benefits stemming from these new global data management concepts on local operating companies, based on the author’s experience in working on international mega trials. Key Words: International trials; Globalization;Clinical data management; Integrated database; Working procedures
THE GLOBALIZATION OF CLINICAL research has occurred as a result of many different factors such as: the continuous and rapid growth of clinical research trials, the increasing complexity of science and technology, and the larger number of steps required for innovation. All of these factors have resulted in more multinational and mega-trials, which are longer, more highly regulated by national and international authorities, must meet strict internal company
Presented at the DIA Workshop “Clinical Data Management” November 4-6 1996, London, United Kingdom. Reprint address: Monica Pirnazzoni. Data Scientist, Data Management Unit. Medical Data Sciences Deparment, Glaxo Wellcome S.p.A., Via Fleming. 4, 37135 Verona, Italy.
requirements, and are much more expensive. Economic, regulatory, and competitive pressures have led the pharmaceutical industry to globalize its operations. Global clinical development is now becoming common, and data from various countries may be used in more submissions. Global development requires an integrated database, so that even if clinical studies are run only in one country, overall safety and efficacy analyses can be performed. Managing the collection, clean-up, and reporting of the clinical data represents a major technical and operational challange. Data management has become a skilled and essential part of this globalization process, and data management professionals need to be conscious of the data management goals that will support the company:
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Motiica Pirnn:;otii
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To reduce data processing time and costs, To improve data qual
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