Quanticate taps CluePoints for data quality oversight
The UK-headquartered contract research organization (CRO) has partnered with CluePoints, a risk-based monitoring (RBM) and central statistical monitoring solution provider, in response to the ICH Good Clinical Practice (GCP) E6(R2) guidelines.
Quanticate also launched in November 2017 an upgraded statistical monitoring service following the release of the updated guidelines, which are designed to streamline clinical trials.
With CluePoints, the company’s new service will provide customers with statistical analytics reports on risk indicators and comprehensive risk signals across all clinical and operational data, according to the company. This will enable sponsors to assess the integrity of trial sites and associated data.
“The combination of the software plus services allows small and mid-size sponsors who don’t have the operational resources to use the leading industry RBM solution delivered by a renowned functional service provider,” said Patrick Hughes, CCO CluePoints.
The partnership is set to last “as long as sponsors see the value of the unique combination of software and services,” he told us.
CluePoints in 2016 signed an agreement with the US Food and Drug Administration (FDA) s to "further explore" a data-driven approach to quality oversight in clinical trials.