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- Title
The Basics of Clinical Trial Centralized Monitoring.
- Authors
Beauregard, Adam; Tantsyura, Vadim; Labrie, Fernand
- Abstract
The article discusses on the centralized monitoring (CM) which is the most efficient way to ensure patient safety, trial integrity, and data quality of the regulatory submissions with a direct impact on the time to marketing approval. Topics include use of CM as a tool within a risk management process; role of CM in increasing the quality of clinical trials as CM allows sponsors to intelligently decrease the amount of costly on-site monitoring using skills required and statistical methods.
- Subjects
PATIENT monitoring; PATIENT safety; DATA quality; CLINICAL trials; RISK management in health facilities
- Publication
Applied Clinical Trials, 2018, Vol 27, Issue 11, p14
- ISSN
1064-8542
- Publication type
Article