Quanticatehas launched its centralized statistical monitoring service as an extension of its statistical consultancy offering in response to recent amendments to the International Conference of Harmonisation (ICH) Good Clinical Practice (GCP) E6(R2) guidelines.
The new service will offer Quanticate’s customers statistical consultancy that incorporates a risk-based approach into clinical trials. As well as introducing measures to evaluate risk into protocol design and statistical analysis plans, the company will also be able to determine the degree of monitoring required by conducting statistical tests guided by a risk-based approach. This will in turn help to guide decisions surrounding investigations into data discrepancies and identifying where site directed monitoring visits may be necessary.
The GCP guidelines are aimed at setting a quality standard when designing, conducting, recording and reporting on trials in humans. The recent ICH GCP E6(R2) addendum advises that incorporating risk-based monitoring approaches into clinical trial design could help companies to ensure the safety and quality of clinical trials by identifying and mitigating risks, as well as ensuring that any incorrect data is identified, in the early stages.
“These new guidelines demonstrate that the industry is recognizing the importance of driving down the cost of drug development and in the long run reducing the cost of medicines for patients,” Dr. Daniel Chapple, director at Quanticate said. “Risk-based monitoring is becoming more popular as it is recognized as a cost effective and efficient method of data analysis. Centralizing statistical monitoring, as opposed to on-site source data verification, can make risk-based monitoring easier as it reduces the need to visit all clinical trial sites for data analysis and verification as it can be outsourced to one supplier, reducing time and resource.”