Statistical Monitoring Applied to Research Trials

While the detection of deliberate (fraud) or unintentional errors concern pharmaceutical and biotechnology companies enormously, there is currently no integrated and automated system to monitor the quality of data based on statistical tests and artificial intelligence or data mining. IDDI is a pioneer in the field, developing and validating an automated system to conduct statistical controls and monitor data quality in clinical trials, primarily based on multiple statistical tests whose results can be exploited by data mining tools and artificial intelligence – not only to detect data anomalies due to errors, but also negligence and fraud – potentially leading to devastating results.

This methodology and software will meet the critical requirements of sponsors for clinical trial data by:

  • reducing risks during submissions to regulatory agencies (FDA, EMA), providing a quality certificate for the final clinical trial data;
  • reducing the time to study analysis and the cost of clinical trials by optimizing on-site monitoring and labour-intensive data verification.

 

Consortium

Companies: IDDI, GSK Biologicals

Universities: Université Libre de Bruxelles, UCLouvain