The company’s new RADAR service leverages statistical interrogation of clinical and operational study data to identify sites with anomalous, missing, or inconsistent data that may require inspection readiness action.
Patrick Hughes, CluePoints Chief Commercial Officer told us the recent launch of CluePoints’ RADAR service helps support companies with clinical data quality improvement, as well as potentially helping companies identify the sites that the FDA might select for inspection after data is submitted.
“This can also help sponsors plan for the own pre-submission audits and ensure quality of the data ahead of submission,” explained Hughes.
The company has seen multiple issues with data quality , some unintentional, such as miscalibrated equipment, or “site sloppiness,” in which Hughes explained staff may not have been trained adequately or follow procedure.
“More malicious causes do exist,” Hughes added. These causes include tampering with data and fraud where there is an intention to cheat and falsify the data, for example, site staff filling out patient diaries or inventing patients.
“In relation to all of these issues, the RADAR service identifies the typical patterns of data in a clinical trial and subsequently pinpoint exactly where sponsors should be focusing their attention and corrective action,” explained Hughes.