Data management in clinical trials processes, problems, perspectives
被引:0
作者:
Bretschneider, M
论文数: 0引用数: 0
h-index: 0
机构:
SKM Creat Res Solut GmbH, D-65195 Wiesbaden, GermanySKM Creat Res Solut GmbH, D-65195 Wiesbaden, Germany
Bretschneider, M
[1
]
机构:
[1] SKM Creat Res Solut GmbH, D-65195 Wiesbaden, Germany
来源:
PHARMAZEUTISCHE INDUSTRIE
|
2004年
/
66卷
/
5A期
关键词:
clinical data management;
data acquisition;
'dirty' data;
electronic data capture (EDC);
D O I:
暂无
中图分类号:
R9 [药学];
学科分类号:
1007 ;
摘要:
In the financial and business world data management today is a highly integrated, automated and standardized process which has led to great cost savings and improved efficiency. The real-time availability of relevant data to decision makers and customers alike, as well as the widespread use of the latest information technology (IT) and quick adoption of new standards is commonplace in those sectors of the industry. In contrast clinical data management in the pharmaceutical industry uses a much more conservative approach and is still mainly reliant on paper for a great part of its processes. This article aims to describe the reasons for this apparent inefficiency by examining the individual aspects of data management in clinical trials and showing perspectives offered by modern information technology as well as its limitations.