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VIEW ROLESThe Functional Service Provider (FSP) model has evolved significantly over the years, offering a range of solutions that cater to the diverse needs of pharmaceutical companies. Initially, FSP was predominantly utilized by large pharmaceutical companies. However, its benefits have become increasingly apparent in mid-sized pharma companies, prompting a shift in outsourcing strategies across the industry.
The FSP model provides flexibility, allowing companies to select the best solutions for different functions. It enables direct control over portfolio priorities through timely resourcing shifts, offers greater control and oversight, and improves site relationships and communication between studies and meetings. These advantages make FSP an attractive option for companies looking to optimize their outsourcing strategies.
The drug development landscape is undergoing continuous change, creating new challenges and opportunities. Advanced drug modalities, such as gene therapy and RNA-based therapies, are on the rise, with approximately 4,000 clinical trials currently underway. These high-risk, high-reward opportunities require careful planning and execution to avoid costly mistakes, especially when they fall outside a company's usual areas of expertise.
The drive towards patient-centric approaches and automation has led to a significant increase in the use of clinical technologies, such as eConsent and connected devices. Additionally, rapid advances in AI and machine learning are set to have a profound impact on drug development in the coming years. The regulatory landscape is also evolving, with new requirements at regional and country levels, such as the implementation of EU CTR regulations, adding complexity to drug development processes.
To stay current, drug companies must either invest significantly in developing and maintaining internal capabilities or find alternative solutions, such as leveraging external companies to manage these challenges. The FSP model offers a viable solution, providing the necessary resources and expertise to navigate this complex landscape.
While some companies have managed to balance challenges and reduce development costs, many have seen significant cost increases. Protocol amendments, missed enrollment targets, and patient enrollment issues contribute to higher costs and delays. The pandemic has also impacted clinical trials and site turnover, with 58% of sites reporting increased turnover over the past couple of years.
There is a trend towards FSP solutions to address these challenges. By leveraging FSP models, companies can achieve greater control and transparency around trial management, extend internal capabilities, and achieve cost savings. Quality, efficiency, speed, and flexibility are also important factors driving the adoption of FSP solutions.
Drug development companies are reassessing their outsourcing strategies, reducing the number of CRO partners, and moving towards more flexible solutions. While there is still significant demand for traditional staff augmentation models, many clients are looking for enhanced support or capability models, such as FSP manage, hybrid, or flexible solutions.
These models offer a range of benefits, including greater control over key decisions, the ability to extend internal capabilities, and cost savings. By leveraging existing internal resources and working with client systems and SOPs, FSP solutions can lead to more streamlined, efficient, and rapid delivery processes.
Mid-sized pharma companies face additional challenges due to their limited size. They may lack resources or capabilities for new or complex areas, access to effective technologies, or cost-effective teams. These companies need to be creative and strategic in managing resources and budgets for drug development.
FSP solutions offer a way to address these challenges by providing the necessary resources and expertise without the full investment needed to develop or maintain internal capabilities. By selecting the right partner and tailoring solutions to fit their specific needs, mid-sized and smaller pharma companies can achieve their drug development goals more effectively without the full investment needed to develop or maintain internal capabilities. By selecting the right partner and tailoring solutions to fit their specific needs, mid-sized and smaller pharma companies can achieve their drug development goals more effectively.
FSP solutions offer several benefits, including greater control and transparency around trial management. Clients can retain ownership of key decisions, extend internal capabilities, and achieve cost savings. Quality, efficiency, speed, and flexibility are also important factors driving the adoption of FSP solutions.
Flexible sourcing models, such as FSP enhanced or hybrid solutions, allow companies to have resources and capabilities available when needed without maintaining them full-time. This flexibility can provide significant benefits, including cost savings and improved delivery processes.
Determining the best partnership to achieve long-term goals involves understanding the different delivery models and their advantages and disadvantages. FSP models can be tailored to fit the client's specific needs, providing the necessary resources and expertise to support drug development.
Different delivery models include FSP with client ownership, managed staffing, staff augmentation, fully outsourced, and hybrid models. Each model offers varying levels of client oversight and responsibilities, allowing companies to choose the best fit for their needs.
Designing and implementing the optimal flexible sourcing solution requires strong communication, trust, and alignment of goals. The methodology includes building, managing, and innovating the delivery model, with a focus on people, processes, and technology. A robust change management plan is crucial for smooth transitions and ongoing progress.
During the implementation phase, it is essential to evaluate the full delivery life cycle and determine priorities and long-term needs. This involves drilling down into the people, processes, and technology pieces to ensure the right support structure is in place. Once alignment is reached, execution becomes the primary focus, with an emphasis on staffing, performance and quality management, and engagement and retention.
Post-execution, the focus shifts to continuous improvement initiatives and understanding the advantages of an FSP partnership. Strong governance and executive-level support are crucial to ensure the partnership meets its goals. Continuous collaboration and coordination are key to reducing cycle times and capitalizing on the momentum from the implementation and execution phases.
Tailoring solutions to fit the client's setup is essential for a successful FSP partnership. Clear SOPs and regional breakouts create streamlined communication pathways, ensuring that the FSP partnership aligns with the client's internal infrastructure and supports their long-term goals.
The evolution of FSP models towards more flexible and tailored solutions opens new opportunities for smaller and mid-sized pharma companies to partner with CROs for efficient, seamless, and cost-effective delivery. By leveraging the expertise and resources of an FSP provider, companies can navigate the complex drug development landscape and achieve their goals more effectively.
For more information on how IQVIA can help you design and implement the optimal FSP solution for your organization, please contact us. Our team of experts is ready to provide custom solutions tailored to your specific needs and support you in achieving your drug development goals.
Decrease clinical development costs and increase study quality using our global functional resources and flexible services, and get more value from your R&D spend.
