[This post analyzes considerations and requirements of a global delivery model for pharmacovigilance.]
The drug safety landscape continues to evolve with the dynamic pharmaceutical marketplace. Increased regulatory requirements, importance of emerging markets, global partnerships across multiple stakeholders and shifting mix of small and large molecules are important factors which mandate a truly global Pharmacovigilance (PV) system. Global resourcing is a key element of this system.Outsourcing in the pharmaceutical market has grown vastly over the last 10 years (1), with the PV market estimated to reach $5b in 2019, at a CAGR of 12.9% from 2013 to 2019 (2).
To effectively deal with the product safety complexities that have increased along all dimensions of science, regulations and operations, a global delivery model, with an optimal mix of in-house and outsourced, and onshore and offshore capabilities is required. Organizations with a corporate presence and a global network of hubs, spokes, and affiliates can deliver against complex requirements in a resource-optimized manner. The corporate safety function, typically located in Europe or the United States, houses most of the global safety activities and is accountable for medical opinion on product safety and risk management. Information and decisions are disseminated by the corporate office to spokes and then to affiliates. Local requirements and the company’s business presence determine the PV operating models and processes at each affiliate. Country-specific business strategies require targeted PV processes and resourcing.
With increasing amount of safety work being delivered by globally dispersed internal and external teams, it is critical to establish sound systems for governance and communication with a rigidly defined and robust framework of Key Performance Indicators (KPIs). This can enable the relationship between the customer and the service provider to reach a different level of maturity and evolve into a strategic partnership. Though reporting timeline compliance is of paramount importance, the focus on quality also increases with outsourcing. Sponsors and service providers partner to define case quality and to monitor it. Contractual agreements include penalties and rewards for compliance with defined Service Level Agreements. This evolution has helped reduce subjectivity from the entire process and encouraged companies to objectively measure quality and the overall performance and health of the engagement.
1. KPMG, 2011. Outsourcing in the Pharmaceutical industry: 2011 and beyond
2. Transparency Market Research, 2014. Pharmacovigilance Market Clinical Trial Phases and Service Providers – Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013-2019
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