Adverse Event Management (Argus)
Our dedicated Adverse Event Management team is optimally integrated with other Xendo teams, like Medical Safety Science, Auditing, QPPV and Regulatory Affairs, combining over 25 years of experience. Additionally, we are experienced with the various agencies (including PMDA, Japan), and can ensure global compliance in an ever-changing regulatory landscape.This places us in the unique position to support our clients with an end-to-end solution to pharmacovigilance.
In addition, we offer safety database hosting in our Argus MT Safety Database. Oracle Argus is regarded as the ‘golden standard’ pharmacovigilance safety database. By applying a multi-tenant approach and by using the Argus workflow manager Xendo has lean processes in place enabling us to offer this software as a cost-effective solution. With this state-of-the-art database, reports for case processing can be generated independently of the size of a corporation. With the Argus Safety Database, Xendo offers the wide scope of activities to biotech, pharmaceutical, and medical device companies of all sizes looking for a cost-effective Adverse Event Management solution.
As the system is very adaptive, all process steps can be managed by Xendo but clients can also choose to perform any of the steps internally (e.g. medical review, QC). Another option is that the client grants access to its own database, allowing our staff to process data in their database environment.
Read more about this cost-effective solution for case processing.
CASE STUDY: Clinical Trial PV Services