CluePoints vision is that it will become the de facto choice as the provider of enabling technology for Risk-Based Monitoring (RBM) and Data Quality Oversight within the industry. At present, CluePoints provides the most comprehensive suite of tools, contained within in its Central Monitoring Platform, and associated consulting support to enable its customers to:

  • Determine upfront risk to a planned study based on the use of the (customizable) TransCelerate Risk Assessment Categorization Tool (RACT). The RACT is an element of the Central Statistical Monitoring Platform and is offered with consulting support based on experience to date.
  • Establish an operational workflow that ensures that all stakeholders within the multi-functional team understand their roles and responsibilities and get what they need from the software itself.
  • Interact with the user-friendly software to determine ‘at risk’ sites, patients, and data and track corrective action to successful conclusion, all within the Central Monitoring Platform itself.
  • Take advantage of a dedicated support team of Data Analysts and Project Managers who are available to ensure that users get the best out of the software and the process, during both the pilot phase of projects and after full implementation of the software itself.

CluePoints has continued to develop the engine that drives its Central Monitoring Platform since the early 2000s – it is designed to detect statistically significant patterns of erroneous data at the country and site level and even down to the individual variable / patient level in order that corrective action can be taken during the course of an on-going study (e.g. via targeted monitoring).Using unique statistical methods not found in any other solution, the software has been designed to offer independent and objective interrogation of both clinical and operational data, leaving no stone unturned in assessing data quality and integrity. It highlights the outlying centers (or countries or regions or patients or critical variables) by measuring the differences between what is normal in the study (the expected values) and the values that are recorded (those observed at a particular site).

The idea behind CluePoints is to provide the ability for the user to drill-down from a high-level perspective – a ranking of all centers from the most to the least dissimilar sites – to a very granular view of the findings to determine data quality and overall study success/risk. The SMART™ engine lies at the heart of the CluePoints solution, and it houses the proprietary suite of statistical algorithms that are used to interrogate and analyze both the clinical trial and operational data sets.