Quanticate, a data-focused clinical research organisation (CRO), has announced that it has partnered with CluePoints to utilize their software to drive the statistical analysis to perform data integrity checks on all types of monitoring and investigator site data as part of its new Data Quality Oversight service that enables centralized statistical monitoring, in response to the amendments to the ICH Good Clinical Practice (GCP) E6(R2) guidelines.
By partnering with CluePoints, Quanticate’s new service will offer customers the creation of statistical analytics reports on key risk indicators and comprehensive risk signals across all clinical and operational data, which enable sponsors to interpret findings to assess the integrity of their trial sites and associated data. Such reports can be examined and allow for corrective and preventive measures to ensure the highest data quality and avoid errors that may otherwise may have gone undetected until submission review by the regulatory bodies.
“Data Quality Oversight is a key component of risk-based monitoring (RBM) to ensure that data is submission ready. When a biometrics CRO like Quanticate does not conduct the monitoring it can focus on quality oversight of site data and then provide guidance to sponsors” explained Karen Ooms, EVP and Head of Statistics at Quanticate. “The CluePoints tool performs statistical tests and provides visualisations for users to quickly identify outliers and various atypical data patterns indicative of operational risk, and enables Quanticate Statistical Consultants to provide guidance and recommendations so that a sponsors trial can take on a Risk based approach. CluePoints have established themselves in the market with endorsement from the FDA and the fact that centralized statistical monitoring can be performed across all investigative site data, not just subject data is highly valuable” Karen Ooms continued “selecting CluePoints is just the first step of a larger solution we are developing and looking to provide for any pharmaceutical, biotechnology or medical device company that do not currently have centralised statistical monitoring capabilities in-house to support data quality integrity for submission and RBM erroneous data identification, or those that do but require a more sophisticated statistical approach to their existing monitoring plans”
Dr Daniel Chapple, director at Quanticate said: “By partnering with CluePoints we have the tools to provide statistical insights into a trial to improve data quality on an ongoing basis and to support a RBM approachwhich has grown in popularity due to the ICH GCP E6(R2). The importance of high quality statistics is the foundation that Quanticate is built on and having industry leading tools in place together with expert statisticians puts us in an ideal place to provide high quality, independent statistical oversight to avoid surprises at submission. Centralised statistical monitoring is not just a feature of full service clinical monitoring CROs, as data experts such as ourselves, we can offer guidance and statistical advice that is independent to a full service CRO.” The CluePoints tool enables Quanticate’s statistical consultants the ability to quickly discover potential outliers and erroneous data rather than waiting for issues to be identified during the submission process which can cause long and costly delays to pharmaceutical companies.”
Patrick Hughes, Chief Commercial Officer at CluePoints reinforced the value of the relationship: “Over the last 5 years CluePoints has seen a growing demand for Central Statistical Monitoring and Data Quality Oversight to create greater cost and resource efficiencies within clinical trials. Quanticate’s deep domain expertise in statistics and data management coupled with a comprehensive and rigorous suite of risk-detection algorithms from CluePoints gives BioPharma sponsors the ideal combination of software and service to improve data quality and integrity whilst complying with regulatory requirements. In the future we anticipate that this approach will be used in every trial to effectively reduce risk and improve quality.”.
CluePoints® is a Risk-Based Monitoring and Central Statistical Monitoring solution that has been designed and perfected over the last 10 years. It employs unique statistical algorithms to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA and EMA, CluePoints® is deployed to support traditional on-site monitoring and to drive a Risk-Based Monitoring strategy. The value of using CluePoints® lies in its powerful and timely ability to identify anomalous data and site errors allowing improvement in clinical data quality, optimization of on-site monitoring and a significant reduction in overall regulatory submission risk.
Quanticate is a global data focused clinical research organisation (CRO) primarily focused on the management, analysis and reporting of data from clinical trials and post-marketing surveillance. Quanticate provides high quality teams that offer efficient outsourcing solutions for clinical data management, biostatistics, SAS programming, centralised statistical monitoring, medical writing and pharmacovigilance. Quanticate can offer study level support, functional service provision (FSP), strategic full data-services solutions or technical consultancy to meet the needs of pharmaceutical, biotechnology and device companies across the globe.Visit www.quanticate.com for further information.