Statistical monitoring services in response to ICH GCP E6(R2) addendum reduce time and resource

Offers customers a comprehensive, risk-based approach to the monitoring of data quality throughout the course of a study.

Quanticate has launched its centralised 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.

Statistical monitoring services in response to ICH GCP E6(R2) addendum reduce time and resource

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.

Dr Daniel Chapple, director at Quanticate said: “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.

“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.

Quanticate’s decision to introduce its new centralised statistical monitoring service has been driven by the niche CROs commitment to streamlining clinical data management and analysis for its customers.

Alan Morgan, Chief Operating Officer, said: “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.

“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.”

Quanticate will be launching the new service at the annual Partnerships in Clinical Trials 2017 conference in Amsterdam between 28th-29th November 2017. Visit stand 19.

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