CluePoints’ Central Statistical Monitoring Software Adds Integrity To Clinical Trials

By Benjamin Ross 

March 30, 2017 | 2017 Best Practices Awards | If you asked the staff at CluePoints about the state of risk-based monitoring (RBM), they would probably tell you that the current process is antiquated at best. In fact, according to CluePoints, clinical site monitoring has almost exclusively been carried out through onsite visits done routinely every four to eight weeks; the process also calls for employing 100% Source Data Verification (SDV) in order to prove data quality or identify issues.

The Belgium-based company believes there is a simpler way to attain this information, and that is where CluePoints’ Central Statistical Monitoring (CSM) software comes in. CluePoints’ software uses algorithms in order to determine the quality, accuracy, and integrity of clinical trial data during and after the conducting of a study. This approach won over the judges of the 2017 Clinical Informatics News Best Practices Awards, earning CluePoints the Best Practices Award for Clinical Data Intelligence. CluePoints’ winning entry was announced at the recent Summit for Clinical Ops Executives (SCOPE) in Miami, Florida.

Considering the various incarnations of regulatory guidance, from the FDA to the EMA, CluePoints’ software becomes quite appealing for biopharma companies to drive risk-based monitoring, but to also be compliant to regulations, which emphasize a greater scrutiny of the data on behalf of the sponsor companies themselves.

Patrick Hughes, CluePoints’ Chief Commercial Officer, told Clinical Informatics News that there’s quite a lot of utility in the type of work that CluePoints is doing, not just in risk-based monitoring, but in different ways to improve data quality within the research that’s being studied. “For example, we do vendor oversight on behalf of some companies, particularly where they have the full-service CRO, and that CRO has promised to get them from study start to database lock on time and on budget. CluePoints can be used to make sure that the sponsor retains control over the quality and integrity of the data by regular analyses of the clinical data that’s being managed by the CRO.”


CluePoints’ CSM software, driven by their SMART engine, offers companies the ability to check data quality objectively across trial sites, subjects, and countries. This is achieved using unique statistical methods, which pave the way for data consistency, while also documenting anomalies.

The CSM software provides a plethora of tools to the user, including CluePoints’ Risk Assessment & Categorization Tool (RACT), a cloud-based workbench that identifies, interprets, and documents study risk factors. By implementing these features, users can select appropriate Key Risk Indicators, and compose analyses in order to determine a risk mitigation plan based on risks that are study-specific.

“There are a number of different prospects [for CluePoints] that extend beyond what might be known at the moment in the industry of risk-based monitoring,” Hughes said. “But all [of CluePoints’ prospects] have to do with the general concept of using this particular algorithm to increase the quality of the study.”

The software was used effectively in a large phase III cardiovascular trial where information about investigational product administration by patients was collected at the clinical trial sites before randomization, and through patient diaries after randomization using ePRO devices.

CluePoints’ entry in the Best Practices Awards described how the sponsor wanted a fast and efficient solution to detect potential issues at the study sites and in patient data. CluePoints conducted an overall data quality management assessment of the sponsor’s data throughout the course of the trial.

A case of fraud was detected by CluePoints’ CSM software after the unusual timing of entries from different patients caught some attention at one site. This instance would have gone undetected if not for CSM techniques being applied to data from the ePRO devices.

Recently, CluePoints has introduced patient profiles into the software solution, which is currently in beta testing. The update will be in the production environment for use by customers by next month. “That’s a really interesting concept,” Hughes said. “The beauty of this type of approach is we’re harnessing the power of the statistics to be able to search through profiles that are most anomalous, that have the most potential for discrepancies.”


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