LONDON (UK) – Quanticate, a data-focused (CRO), has announced that it has partnered with CluePoints as part of its new service.
Quanticate’s new service enables centralised statistical monitoring in response to the amendments to the ICH Good Clinical Practice (GCP) E6(R2) guidelines.
By partnering with CluePoints, Quanticate 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.
These reports allow for corrective and preventive measures to be taken that 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 and ensures that data is submission ready.
“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 thatcan be performed across all investigative site data, not just subject data is highly valuable.
“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 added: “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 approach.
“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.
he CluePoints tool enables 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.”