Data Analysis & Study Planning

Prof. Johannes C. Vester

Centralized Statistical Monitoring and Control of Ongoing Studies

Standard on-site statistical monitoring is a well-known way to improve the quality of data, but it is costly and not very efficient. In the last 10 years idv has developed highly efficient, powerful, risk-based tools for controlling the way in which studies are conducted. FDA and EMA Guidelines on risk-based monitoring, released in 2011 provide the regulatory framework. The ICH E6(R2) Addendum from June2015, implementing the requirement of a risk-based approach, completes a quantum leap in clinical trial quality assurance. Sponsors of studies will be pleased to hear that more than half of the usual costs of standard on-site monitoring can be saved using sophisticated risk-based centralized statistical monitoring methodology.

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Technical Publications: 48

Overall Publications: 156

Overall clinical research projects : 800+