CluePoints, a provider of risk-based study execution (RBx) and data quality oversight software, will work with clinical solutions company Parexel in a strategic collaboration to navigate global clinical data acceptance regulatory requirements using central statistical monitoring (CSM).
Parexel and CluePoints will work together to bolster the quality and accuracy of clinical trial data during and after the study, as well as using risk-based monitoring to increase productivity and cost-effectiveness for sponsors.
The ICH E6 (R2) created new requirements to facilitate the mutual acceptance of clinical data by regulatory authorities across the US, EU, and Japan. With this guidance, there has been an increased need to generate accurate, high-quality data.
CluePoint’s CSM technology will be used to identify risk in data from pre-study assessments and prior to regulatory submission through on-site monitoring. Patrick Hughes, CCO of CluePoints told us that the company's service enables Parexel the opportunity for unsupervised and objective analysis of all clinical and operational data to identify any potential issues and course correct in a timely manner.
Gadi Saarony, EVP and chief clinical research services officer at Parexel, said in a statement, “The addition of the CluePoints’ central statistical monitoring (CSM) solution enables us to look at risk-based monitoring differently and from a holistic point of view so that we can focus monitoring activities where they are needed, ultimately driving increased efficiency and productivity while identifying and addressing risks before problems arise.”
Patrick Hughes, CCO of CluePoints, said, “Our vision of RBx, where independent data interrogation, comprehensive analysis, and resulting actions become reusable knowledge, is enabling the industry to progress efficiencies and further improve quality for sponsors.”
