Summary of Themes Whitepaper on Company Response to the New ICH E6 Revisions
Download the whitepaper to learn:
- How companies are responding to the ICH E6 Addendum
- What areas are most expected to be impacted
- What revision elements show the widest differences in interpretation between companies
- What challenges companies have seen
The Principles of Central Statistical Monitoring
CluePoints showcases the principles of Central Statistical Monitoring as advocated by the various regulators in their guidance on the topic of Risk-Based Monitoring.
- The practical implementation of the methodology
- Case studies that identify the various data discrepancies and anomalies
- How to increase data quality and reduce costs through the practical implementation of CluePoints
Ensuring Trial Validity by Data Quality Assurance and diversification of monitoring methods, Clinical Trials published in 2008
Central Statistical Monitoring as advocated by the regulators in their guidance documents on the topic of Risk-Based Monitoring and Data Integrity Assurance.
- The types of errors arising in randomized trials, and the circumstances under which they might introduce bias or adversely affect patient safety during the trial
- The types of monitoring techniques available and their efficacy for detecting the types of errors we have identified
- How risk assessment can be used to identify the likelihood of those errors, thereby guiding the monitoring plan
Statistics in Medicine – The Role of Biostatistics in the Prevention, Detection and Treatment of Fraud in Clinical Trials – Statist. 1999
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.