Perspectives in Clinical Research

QUALITY
Year
: 2011  |  Volume : 2  |  Issue : 2  |  Page : 54--58

Strategies for ensuring quality data from Indian investigational sites


Antal K Hajos1, Sujal K Kamble2 
1 Managing Director, Procelsis Consulting, Germany
2 Associate Partner Asia-Pacific, Procelsis Consulting, Germany

Correspondence Address:
Antal K Hajos
Am Farnberg 3, 79289 Horben
Germany

The topic of ensuring quality and compliance is and must be a top priority in the conduct of clinical trials, as warranted by regulatory guidelines as well as the inherent responsibility of the professionals conducting such research. Fast-growing emerging clinical geographies such as India demand special attention due to rapid growth and associated factors that may put study quality at risk. In this paper, we used the basic principle of PDCA (Plan, Do, Check, and Adjust) to structure the processes of a clinical trial from protocol to final analysis in order to highlight the interactive nature of involved people and processes required to ensure quality of data and site functioning.


How to cite this article:
Hajos AK, Kamble SK. Strategies for ensuring quality data from Indian investigational sites.Perspect Clin Res 2011;2:54-58


How to cite this URL:
Hajos AK, Kamble SK. Strategies for ensuring quality data from Indian investigational sites. Perspect Clin Res [serial online] 2011 [cited 2023 Jan 31 ];2:54-58
Available from: http://www.picronline.org/article.asp?issn=2229-3485;year=2011;volume=2;issue=2;spage=54;epage=58;aulast=Hajos;type=0