Ashfield Pharmacovigilance was hired to provide case management augmentation to a top ten (10) global pharmaceutical company. The company required an experienced drug safety group who not only could enter data effectively, but could strategically add value to this company which was initiating a new database (Argus), workflow and infrastructure while also integrating an outsourcing provider (Ashfield Pharmacovigilance) into the workflow.
Ashfield Pharmacovigilance effectively managed 500 cases each month (serious, non-serious, literature, and legal) for this client from start to closure. Submissions were performed by the client. Ashfield Pharmacovigilance utilized a train-the-trainer concept for initial and ongoing training and adhered to all required service level metrics as follows:
Overall, this was a successful partnership. Steering and Core teams were established to govern the relationship, ensuring open and frequent communication regarding the project. Ashfield Pharmacovigilance also contributed to process improvements, provided a huge degree of flexibility and seamless integration, as well as quality and value to this client’s internal department.