Following the recent amendments to the International Conference of Harmonisation (ICH) Good Clinical Practice (GCP) E6(R2) guidelines, data-focused clinical research organisation (CRO), Quanticate, has launched its centralised statistical monitoring service.
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This new service will offer customers a statistical consultancy that incorporates a risk-based approach into clinical trials. In addition to 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.
“These new guidelines demonstrate that the industry is recognising the importance of driving down the cost of drug development and in the long run reducing the cost of medicines for patients,” added Dr Daniel Chapple, director at Quanticate. “Risk-based monitoring is becoming more popular as it is recognised as a cost effective and efficient method of data analysis. Centralising 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.
“Optimising trials by reducing monitoring visits should be welcomed by the pharmaceutical industry and the ICH GCP E6(R2) addendum will help to drive companies towards streamlining clinical trials in this way.”
“Statistics play a key role in analysing and making decisions on study data and Quanticate’s new service offering puts us in an ideal place to support pharmaceutical and biotechnology companies as they opt to centrally monitor their data and introduce risk-based approaches into their study designs,” added Alan Morgan, chief operating officer. “There is a clear sponsor benefit to using an independent company to perform statistical monitoring and validate the work of the organisation driving site and patient recruitment through regular review of study data.
“As a company that specialises in statistics, Quanticate offers customers a comprehensive, risk-based approach to the monitoring of data quality throughout the course of a study.”