Routine Tasks Involving Clinical Trial Cases

axpharma-Pharmacovigilance-essais-cliniques

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.