During clinical development of an investigational drug, periodic analysis is critical to ensure risks to study patients are identified and managed appropriately. The DSUR is a comprehensive annual review and evaluation of pertinent safety information collected during a specified reporting period for a drug under investigation whether or not it is marketed. The objective is to:
- assess whether the information in the reporting period is in accord with previous knowledge
- describe new safety issues and the impact they may have on clinical trial patients
- summarise the current understanding of the potential and identified risks of the investigational product
- provide an update on the status of the clinical programme and study results
Similarly to the PBRER the document should provide assurance to the regulatory authority that the sponsor is adequately monitoring and evaluating the evolving safety profile of the investigational drug.
Essjay Solutions has a network of medical writers and physician support that can provide support for DSUR management and writing. Additionally we can review current processes and provide advice on operational efficiency for DSUR production internally.