|Strategic planning, sourcing and implementation of pharmacovigilance operations are multi-dimensional activities. Over the past few years there has been a considerable increase in the safety processes being outsourced. This trend is largely due to the evolution of mature processes and enhanced awareness of risk mitigation strategies at the expanding vendor base. These help the sponsor focus on core in-house strengths and leverage the service provider’s capabilities.The approach towards outsourcing pharmacovigilance is shifting from being largely tactical towards forming a strategic partnership. Sourcing strategy would vary based on sponsor’s product portfolio, therapeutic areas, internal capabilities, expected case volume, expected complexity of cases, geography of product sales and risk management requirements. For instance, a sponsor might decide to outsource a few steps of the pharmacovigilance process that the organization classifies as non-critical or might outsource the entire process from case receipt to submission. The sponsor would have to make a series of decisions on their preferred nature of engagement like choosing between a pilot and a permanent contract, migration to steady state, vendor management, KPIs (quality, cost, time) and success metrics. This concept paper, based on our proprietary model, discusses facets of a smart sourcing strategy.
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