Why Download this Free Paper?
Marc Buyse, CluePoints’ founder, was already stating as far back as 1999 that Biostatisticians should be involved in assessing clinical data for fraud (as well as unintentional errors), detecting it, and quantifying its impact on the outcome of clinical trials.
Within his white paper, you will find an overview of the role of Biostatistics in the prevention, detection and treatment of fraud in clinical trials. CluePoints showcases the principles of Central Statistical Monitoring to detect data fabrication (making up data values) and falsification (changing data values) as advocated by the regulators in their guidance documents on the topic of Risk-Based Monitoring.
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