The AERS - OC interface provides the pharmacovigilance function with an easy to use web based system to review, update, and synchronise AE/SAE case information received directly into OC/RDC. The user is presented with a list of AEs coming from the clinical data management system and a list of AE cases already known in the pharmacovigilance system.
Integration using the interface adds new functionality to the accepted reconciliation process introducing increased efficiencies and real time accuracy. Both the data management and pharmacovigilance groups will be able to benefit from closer collaboration.