As advised in the FDA Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring “, there is a growing consensus that risk-based approaches to Monitoring such as focusing on the most critical data elements are more likely to ensure subjects protection and overall study quality and will permit sponsors to monitor the conduct of clinical investigations more effectively”. The EMA has also issued a similar reflection paper.
IDDI can provide a full range of risk-based monitoring options,
- by partnering with other Clinical CROs to provide on-site monitoring,
- by using our EDC system for central data review and
- by providing key Risk indicators, alongside the Sponsor’s trial management tools.
LISTEN TO : Buyse, M. (2016), "Statistical methods to detect fraud and errors in clinical trials", in The Biomedical & Life Sciences Collection, Henry Stewart Talks Ltd, London