Extensively revised and updated, with the addition of new chaptersand authors, this long-awaited second edition covers all aspects ofclinical data management. Giving details of the efficient clinicaldata management procedures required to satisfy both corporateobjectives and quality audits by regulatory authorities, this textis timely and an important contribution to the literature.
The volume:
* is written by well-known and experienced authors in thisarea
* provides new approaches to major topics in clinical datamanagement
* contains new chapters on systems software validation, databasedesign and performance measures.
It will be invaluable to anyone in the field within thepharmaceutical industry, and to all biomedical professionalsworking in clinical research.
Richard K. Rondel
Datenorganisation Klinische Prüfung Medical Science Medizin Medizin, Pharmazie / Allgemeinmedizin, Diagnostik, Therapie Pharmacology & Pharmaceutical Medicine Pharmakologie u. Pharmazeutische Medizin
"The key to enduring research is data quality and data qualitydepends upon data management. How fortunate then that the start ofthe New Millennium sees the publication of the second edition of'Clinical Data Management'. ... Admirably concise andauthoritatively penned, it provides an excellent introduction to asubject at the heart of pharmaceutical R&D.", Dr Hugh Boardman,Partner in Boardman Clarke, Pharmaceutical Physician#
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