Title : End-to-end pharmacovigilance support

Client Situation

A North American generic pharmaceutical company undertook an evaluation of its processes across the R&D organization to classify activities into core and non-core, with the aim of making certain outsourcing decisions. Risk management and mitigation planning was considered core and had to be retained in-house. Case processing and aggregate report writing was identified as a primarily non-core activity, but given its importance from a regulatory compliance perspective, oversight and control of the process was an important core task to be retained in-house. The client engaged Sciformix to provide pharmacovigilance services for its portfolio of 350+ products across North America, Europe and Australia.