Case Studies

First Outsourcing Experience for a Global Veterinary Pharmaceutical Company

Pharmacovigilance / Global

 

Insight

Our client had never outsourced veterinary drug safety case management and preferred to maintain their database in-house. The client’s internal drug safety staff were doubtful that an outsourcing provider would be able to deliver similar quality and metrics as in-house personnel.

When the client launched new lines of products, it became increasingly difficult to keep up with increased case volume and efficiently manage seasonal fluctuations.  Senior product safety staff wanted to be able to put emphasis on building core pharmacovigilance and regulatory expertise in-house.

Idea

Ashfield Pharmacovigilance’s strategy was to begin with processing cases for one product line and gradually was to begin with gradually increase product lines overtime.  During the project initiation phase, the client trained Ashfield Pharmacovigilance on all facets of case processing and submission in the client’s safety database.

Ashfield Pharmacovigilance began the transition by performing only specific steps in case processing to allow the client to evaluate Ashfield Pharmacovigilance’s ability to keep up with case volume and maintain superior quality.  The client closely scrutinized all cases to ensure consistent quality and provide continuous feedback to Ashfield Pharmacovigilance.

Impact

Ashfield Pharmacovigilance processed in excess of 47,000 cases annually and consistently demonstrated the ability to manage fluctuating case volume, including seasonal spikes in report numbers while maintaining quality metrics and avoiding the need for the client to increase internal resources.

The client was able to refocus existing staff to enhance core product safety capabilities.  Ashfield Pharmacovigilance assumed responsibility for training all new client pharmacovigilance staff on case processing and submission.

Reflecting our values

Ashfield Pharmacovigilance exceeded quality and provided a true partnership to a client who had never outsourced to animal safety and preferred to maintain their safety database in-house.  With their expertise and ingenuity, Ashfield Pharmacovigilance was able to take full responsibility for the tactical components of safety monitoring for their product line.

Testimonial

“Outsourcing our pharmacovigilance case management to Ashfield Pharmacovigilance has proven to be a very efficient strategy to focus our internal resources to the customer and business sides of the process.  The transition to outsourcing was seamless and made easy by a highly collaborative team approach at Ashfield Pharmacovigilance.  Their ability and willingness to work as part of our team made the process work smoothly.

Overall, Ashfield Pharmacovigilance’s engagement and professionalism has made the outsourcing of our pharmacovigilance services a very positive experience.”

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