Best Practices to Ensure Success

In 2006 biotechnology and pharmaceutical companies outsourced more than $12 billion of global R&D spending; this amount is expected to rise by around 12 per cent each year over the coming decade according to Frost & Sullivan. Spending on outsourcing for Phase IV services, including pharmacovigilance, is projected to increase at an even greater rate of 17 per cent during the same 10- year period. This pattern of growth reflects the globalisation of drug development, the increased activities of lifecycle management and a more stringent regulatory environment. As outsourcing gathers momentum, more types of services are being requested, and the impact on outsourced pharmacovigilance services is particularly significant.

Outsourced safety services in the past have had limited scope. Traditionally, pharmaceutical companies have always outsourced SAE/ADR management, pharmacoepidemiological studies and individual consultancy but concerns about confidentiality, data security and liability in cases of regulatory non-compliance have proven to be important factors against outsourcing. However, the increasing demand for pharmacovigilance capacity and expertise cannot always be satisfied in-house, whether constrained by limited resources or a lack of appropriate infrastructure or regional presence. Consequently the changing industrial and regulatory environment leads to re-evaluation of the advantages and disadvantages of outsourcing pharmacovigilance services.