Clinical Data Management

Beschreibung

Extensively revised and updated, with the addition of new chapters and authors, this long-awaited second edition covers all aspects of clinical data management. Giving details of the efficient clinical data management procedures required to satisfy both corporate objectives and quality audits by regulatory authorities, this text is timely and an important contribution to the literature. The volume: * is written by well-known and experienced authors in this area * provides new approaches to major topics in clinical data management * contains new chapters on systems software validation, database design and performance measures. It will be invaluable to anyone in the field within the pharmaceutical industry, and to all biomedical professionals working in clinical research.

Autor*in

Richard K. Rondel

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Datenorganisation Klinische Prüfung Medizin, Pharmazie / Allgemeinmedizin, Diagnostik, Therapie

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"The key to enduring research is data quality and data quality depends upon data management. How fortunate then that the start of the New Millennium sees the publication of the second edition of 'Clinical Data Management'. Admirably concise and authoritatively penned, it provides an excellent introduction to a subject at the heart of pharmaceutical R&D.", Dr Hugh Boardman, Partner in Boardman Clarke, Pharmaceutical Physician# ".a well-written book and is likely to be of great value to practitioners in the clinical trial arena. I recommend it for the library of such individuals."--Biometrics, September 2000
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