Drug safety outsourcing varies among similar sized firms

26-May-2010 - Last updated on 27-May-2010 at 07:31 GMT

More than 50 per cent of large pharma keep all pharmacovigilance in-house but among smaller firms, and even some big businesses, outsourcing is considerable, according to a new report.

Outsourcing pharmacovigilance can help companies manage workloads, tap expertise and remove the need to add in-house capacity. Despite these benefits, 56 per cent of large pharma companies polled by Cutting Edge Information (CEI) keep all pharmacovigilance in-house.

In a report CEI explains that large pharma companies’ strong technology infrastructure and ability to attract qualified, experienced employees limit their outsourcing. Also, these firms’ portfolios, pipelines and resources make keeping pharmacovigilance in-house practical and feasible.

However, even among large pharma companies outsourcing can account for a significant proportion of pharmacovigilance budget. The report cites a large pharma company which outsources 50 per cent of its pharmacovigilance activities.

Also, a pharma company, which outsources 15 per cent of pharmacovigilance, explains that it uses vendors for risk evaluation and mitigation strategies (REMS). The firm reasons that it is uneconomical to employ a full-time REMS specialist who will only be needed a few times a year.

Every small company polled outsources some of their pharmacovigilance work but the amount varies from 10 per cent up to 80 per cent. Consequently, although in general smaller firms outsource more, there is no consistent standard even among similar sized companies.

Vendor offerings

The poll also looks at companies preferences for outsourcing to vendors who provide turnkey or ad hoc services. Of the large companies polled, 50 per cent choose to outsource each activity separately.

These businesses already have a pharmacovigilance infrastructure in place and use vendors to deal with spikes in demand. This removes the need to hire and fire in-house employees.

In contrast, small and medium sized firms prefer outsourcing partners that can provide turnkey and ad hoc services. The report believes that the flexibility offered by these vendors is attractive to pharmacovigilance departments facing constantly changing workloads and resources.