Routine Tasks Involving Clinical Trial Cases
AXPHARMA carries out the following tasks, on behalf of the sponsor or the Contract Research Organisation, during phase I to phase III clinical trials:
- gathering initial reports on Severe Adverse Reactions (SAR)
- monitoring Adverse Reactions (AR) in search of undeclared SARs
- monitoring and evaluating SARs
- dealing with requests for supplementary data via the investigators
- reporting Suspected SARs to the relevant authorities via EudraVigilance
- submissions to national agencies, in accordance with their requirements
- drafting practical summary reports on all SARs that can be integrated into the trial’s final report
- drafting other reports required by the regulations such as Development Safety Update Reports (DSUR).
AXPHARMA can also support clinical trial hotlines and can manage unblinding outside normal office hours.