Author – Dr. Chitra Lele, Chief Scientific Officer, Sciformix Corporation
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). It has become almost standard practice among multinational companies to develop global sourcing programs that utilize specific geographic and domain expertise, harmonize and standardize processes, integrate new technologies and find ways to manage volume fluctuations to enhance efficiencies and drive cost reductions. The success of these programs depends heavily on its impact on resource optimization, ability to improve compliance with respect to safety and risk management and enabling proactive PV.
The global offshoring trend
Increased focus on safety after a few product recalls in the early part of the last decade, the barrage of new guidances across US and EU in the latter part of the decade and the impending mandate to implement new PV regulations in EU effective 2012 led all organizations to consider resource augmentation and outsourcing models for skill and scale. Large innovator organizations turned to outsource and offshore, starting with call center and data entry of adverse reactions, and adding other pieces as experience and expertise was built. This led to large consulting and IT organizations tapping into this service area. Other biopharmaceutical companies sought assistance of consulting organizations in the US and Europe to build compliant systems and processes and then outsourced and offshored the operational parts. Some small to mid-sized innovator companies and generic manufacturers realized that setting up systems and processes in-house was not the best option, and therefore asked vendors host their databases and outsourced end-to-end PV. Functional service providers came up to provide drug safety services from cost effective geographies. Emphasis on safety across the clinical trial and post-approval continuum also led full-service Contract Research Organizations to offer safety services in a globally distributed model.
The right mix of outsourcing and onshore and offshore capabilities
The complexities of product safety have increased along all dimensions, of science, regulations and operations. To effectively deal with these, 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.
As the amount of safety work that is delivered by globally dispersed internal and external teams increases, it becomes critical to establish sound systems for governance and communication with a rigidly defined framework of Key Performance Indicators. Thus the relationship between the customer and the service provider reaches a different level of maturity and evolves more 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.
Summary
While it has become important to outsource and offshore to tap into the global resource pool in order to achieve highest level of compliance in the most cost-effective manner, it is also important to have a strong central safety function accountable for all aspects of the global PV system, supported by a network of local safety experts to help ensure compliance with all applicable regulations. Thus PV has to be delivered in a truly global model, balancing geographical presence and the internal versus external resource mix. Successful organizations are adopting such new operating models that incorporate the right amount of in-house, onshore and offshore resources.
References
- KPMG, 2011. Outsourcing in the Pharmaceutical industry: 2011 and beyond (Internet) https://www.kpmg.com/Ca/en/IssuesAndInsights/ArticlesPublications/Documents/Outsourcing-pharmaceutical-industry.pdf [Accessed 02/12/2014]
- Transparency Market Research, 2014. Pharmacovigilance Market Clinical Trial Phases (Pre-Clinical Studies, Phase I, Phase II, Phase III, Phase IV or Post-Marketing Surveillance) and Service Providers (In-House and Contract Outsourcing – Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013-2019 (Internet)