CRO launches stat monitoring tech in line with ICH GCP addendum

By Flora Southey contact

- Last updated on GMT


Related tags: Clinical trial

Quanticate has launched an upgraded statistical monitoring service following the ICH’s good clinical practice (GCP) E6(R2) addendum designed to streamline clinical trials.

The data-focused contract research organisation (CRO) said the service is an extension of its statistical consultancy offering, and responds to recent amendments​ to the International Conference of Harmonisation (ICH) E6(R2) guidelines.

The service – which incorporates a risk-based approach to protocol design and statistical analysis plans in clinical trials – could help ensure the safety of trials by identifying and mitigating risks, said the firm. 

“The objective is to make trials more efficient whilst maintaining high quality and protecting patient safety,” ​said executive vice president Daniel Chapple.

Centralising statistical monitoring​ reduces the need to visit all clinical trial sites for data analysis, he added.

According to the CRO, the service is a cost efficient method of data analysis, and would benefit all companies undertaking clinical trials.

“Our functional outsourcing approach for overseeing multiple programmes would be more relevant for larger customers, but our statistical consultancy and review can be outsourced at an individual study level,” ​Chapple told us. 

Niche CRO interest

Quanticate said niche CROs are increasingly looking to streamline clinical data management and analysis.

“Having no link to the investigator sites, the sponsor, the CRO overseeing the site relationship or the principal investigators means that the data quality checks are completely unbiased,” ​Chapple said.

“It adds additional confidence since the ICH guidelines are clear that the sponsor is ultimately responsible for the data regardless of who they outsource to,” ​he added.

ICH is inviting public review and comment on a reflection paper​ on GCP ‘Renovation,’ to provide updated guidance that it says is “both flexible enough to address the increasing diversity of study types and data sources that are being employed to support regulatory and other health policy decisions.”

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