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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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How to effectively outsource functional expertise as your business evolves
Sponsors, whether large, small, established or new, are all facing increasing pressure to achieve their drug development goals with faster timelines, less cost, enhanced efficiencies and nimbleness.
Sep 01, 2022
Sponsors, whether large, small, established or new, are all facing increasing pressure to achieve their drug development goals with faster timelines, less cost, enhanced efficiencies and nimbleness. Some of these sponsors, specifically small-to-mid-size pharmaceutical and emerging biopharma companies, may question if their infrastructure, in-house expertise and capabilities will meet the demands of today and tomorrow’s ever-changing landscape. Functional service provider (FSP) solutions are one way sponsors can lean on external partners to meet their clinical development needs. Such as a FSP Staffing Augmentation solution that offers sponsors the flexibility they need to grow their teams, but can provide so much more to assist with their short term and long term goals.
The key for sponsors, whether first time users or FSP-savvy, is to ensure the FSP partner can deliver a truly customized approach to meet their individual needs. For one, many sponsors are now looking to enhance traceability of progress, where responsibilities typically contracted out to several agency partners are brought into one FSP for efficient oversight and management. IQVIA’s newest FSP service model—the Staffing Augmentation solution—is one such option.
Specifically, there are varying reasons why a sponsor may consider integrating leadership expertise as part of their broader FSP model to help establish and implement necessary standards and processes in place, including but not limited to:
- Creating, training and implementation of standard operating procedures (SOPs).
- Building systems (e.g., sponsor processes and systems audit, metric tracking and mapping validation tools).
- Setting up standards and governance infrastructure (e.g., creating improvements to CDISC process, ensuring standards compliance and building output tools).
- Providing leadership, project oversight and forecasting team/staff hiring and outsourcing (e.g., new technology implementation and overseeing business continuity).
Whichever path a sponsor is on regarding their FSP spectrum of needs, IQVIA can provide them with leadership expertise as an option via its staffing solutions. As business objectives and needs evolve, IQVIA’s team aims to offer flexible functional expert guidance and oversight regardless of the sponsor’s experience with or use of FSP solutions.
New to FSP
For sponsors who are smaller or newly established, there may be gaps in varying in-house strategic expertise and leadership roles to meet short- and/or long-term business goals. They may recognize the need to access expertise from external strategic providers, especially as they may not have the appropriate infrastructure and related budget to hire internally for specific needs. For these sponsors, integrating experts and leaders who have a deep working knowledge of functional business areas can be helpful from a long-term growth perspective
Bringing in a trusted partner, who has diverse experience working with a broad range of sponsors with varying needs, can be an integral part of their internal goal-setting process. This diversity in expertise can be critical to aligning the optimal potential solution for a specific sponsor’s goals, helping to set the groundwork for what functional expertise may be needed to build SOPs, systems, standards and more.
An FSP partner who recognizes the importance of always looking ahead in terms of how a sponsor’s goals may change and grow can help map out functional strategies, direction and related needs in expertise and solutions. For example, biotech companies focused on a single asset may feel pressure to meet their ambitious goals while containing costs. FSP experts can help look across company operations to gauge how best they can spend budget to best meet their goals. At the same time, it is important to forecast where budget will need to be invested as the company’s asset(s) and development goals change or expand. Market changes will also need to be considered.
As the business evolves, there may be changes in staffing needs. A dedicated FSP partner can help ensure sponsors have consistency in their FSP team—keeping staff who have institutional knowledge in place and integrating additional staff based on the functional needs at hand and for the long haul. Depending on the direction of development, this can include bringing in strategic partnership leads, regulatory submission strategists, CDISC specialists and more.
FSP-savvy sponsors
Typically, established large pharmaceutical and biotech sponsors have a vast amount of collected experience within a specific functional role, such as data management and statistical programming. Within these roles, there are established processes as well as closely-managed metrics. However, within these established SOPs and systems, it is still possible through a fresh set of eyes, to look for and to create efficiencies. Allowing for a FSP expert to examine and highlight ways to enhance SOPs, systems, infrastructure and more can be useful to meet sponsor goals. For example, for one global pharmaceutical company, making adjustments to better navigate their programming system helped ensure the sponsor’s internal teams of programmers were more efficient in their work streams, both impacting the FSP and how the sponsor uses its own resources.
Understanding that every sponsor is unique in its culture, processes, resources and needs, the IQVIA FSP team leverages previous experience and knowledge with individual sponsors to best determine where improvements can be made and how to successfully operationalize them based on where the sponsor is looking to go in terms of business goals and growth.
The FSP Staffing Augmentation offers sponsors the flexibility they need to grow their teams, but can provide so much more to assist sponsors with their short term and long term goals. Whether you are a large pharma or small Biotech or somewhere in between, the evolution of the FSP Staff Augmentation solution has grown way beyond the traditional staffing from years ago. FSP Staffing partnerships have evolved into partnerships in which value, strategy and entire departmental efficiencies are now the outcomes of the truly modern staff augmentation model.
If you’d like to learn more about our FSP models and options or would like to discuss how we can help you across data science functions, please contact: globalfspgtm@iqvia.com.
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