Abstract
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.
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