The clinical development industry is at a crossroads, facing significant challenges while simultaneously encountering unprecedented opportunities for innovation. Economic pressures, talent shortages, geopolitical instability, sustainability concerns, and intensifying competition for sites and patients are exerting considerable strain on the industry's mission to bring new therapies to patients. Concurrently, there's unprecedented optimism surrounding available and emerging technologies, data applications, and process innovations that promise to revolutionize the clinical development landscape.
The deployment and implementation of these solutions present a formidable challenge. As one of the most heavily regulated and complex industries globally, the established operating model and infrastructure of clinical development was not designed for agility. Historically, this approach was appropriate given the gradual pace of change. It has resulted in a matrix-based, fragmented, occasionally locally managed model that resists change.
With clinical research expected to grow by 6.49% each year through 2030, the industry is constantly searching for new efficiencies in an increasingly competitive and crowded market. The conflicting goals of reducing short-term costs while investing in new systems and technologies have led the industry to seek novel strategies for adopting critical innovations to accelerate development timelines and deliver the next generation of novel patient therapies.
Current Outsourcing Landscape
Clinical development outsourcing began nearly two generations ago, primarily along two distinct paths:
- Functional Staffing Model (FSP): Biopharmaceutical companies rely on Clinical Research Organizations (CROs) to augment their existing teams. The operating model remains essentially internal to pharma organizations while CROs are responsible for finding, onboarding, training, and retaining talent. The FSP model enables biopharmaceutical companies to outsource entire functions to augment their internal staffing or to fully manage these functions across their portfolio of studies.
- Full-Service Outsourcing (FSO): This model assigns broader responsibilities to CRO partners, including accountability for performance for overall study delivery, task performance, and resource management. The primary advantages include optimized resource allocation per study, access to specialized operational expertise, and avoidance of large institutional investments in technology and process innovation by utilizing CRO process and technology.
In recent history, clinical development has been almost equally split between in-house biopharma resourcing, FSP-supported resourcing, and fully outsourced trials. Some large organizations have developed a global patchwork of models due to organic growth and acquisitions, resulting in decentralized decision-making on model and vendor choices.
A Shift Toward FSP
While both FSO and FSP models remain strong, there's an undeniable increase in FSP adoption. This trend is evident from the requests for proposals and early consultative engagements across the industry. FSP can enable biopharmaceutical companies to respond to macroeconomic trends, labor market evolution, geopolitical environments, and regulatory changes in an agile manner. By outsourcing entire functions, biopharmaceutical companies can rapidly shift areas of focus to accelerate drug development and adjust quickly to new demands. However, this shift is not a simple pendulum swing away from FSO. What we're observing is an evolution towards a more sophisticated and agile outsourced model – a balanced and strategic approach that leverages the core strengths of each model in a more bespoke manner.
The emerging outsourcing strategy is to apply the right model to the right situation to continuously adapt to changing technology, skills, and geographies. Three of the common drivers of transformations to FSP are described below.
- Internalizing processes and systems: Many pharmaceutical companies are establishing a uniform platform to conduct all trials on the same in-house systems and processes. This strategy is supported by the expanding role of data beyond trial submission and the establishment of core technology platforms as industry standards. Once a single in-house platform is established, applying an FSP workforce becomes a logical next step. However, careful planning and phased implementation are crucial to avoid disruption to sites and patient safety.
- Shifting labor to lower-cost hubs: The need for immediate cost savings is driving many pharma organizations to explore offshoring options. While offshoring has been used in clinical development for over 25 years, recent years have seen an increase in traditional in-country roles moving to hub locations, coinciding with new operating models and remote monitoring practices. FSP models are often utilized to leverage CROs' established footprint, scale, and ability to develop and retain talent in these hubs.
- Accessing new or divested geographies: Two opposing forces contribute to the need for an FSP strategy to access patients. Cost containment initiatives are leading many pharmaceutical organizations to streamline their in-country footprints, creating gaps in their ability to start up and oversee sites in certain locations. Simultaneously, clinical trials are rapidly expanding into jurisdictions not directly supported by pharma companies in order to reach a diverse population of patients. An FSP model is key to ensuring that internally run trials are not geographically limited by the biopharmaceutical company’s footprint.
Myths and Misconceptions about FSP
There are several misconceptions regarding the adoption of FSP models that need to be addressed.
Lower Cost: While the bill rate for resourcing in FSP appears lower, these are only the direct costs. In FSP, the biopharmaceutical company takes on additional responsibilities typically supported by non-billable roles in the CRO, including resource management, technical line management, quality management, systems and process maintenance, and therapeutic expertise. Additionally, the biopharmaceutical company becomes responsible for optimizing resource utilization.
Faster Implementation: The speed of implementation is based on processes, decision-making, and supporting technology rather than the model itself. CROs' full-service processes are designed to overperform due to direct financial benefits tied to faster task completion. Both FSP and FSO models have the potential to be equally fast, given the right processes, effective oversight, and excellent execution.
The Optimal Model
Most organizations have never been fully FSP or fully FSO. A blended approach has always existed, based on two parameters: function and study. For example, safety services often use a functional delineation, with the majority being FSP with a single vendor, even when the clinical trial itself is fully outsourced to various partners or managed in-house. Similar strategies apply to data operations and medical writing services for FSP.
Using the study as the defining criteria, many organizations select an outsourcing model based on factors such as the phase of the study, therapeutic area, priority/urgency, or other study/asset-specific considerations. Furthermore, some trials are truly hybrid based on the geographic location of the sites.
The emerging trend is to establish structured decision-making criteria to determine which operational and outsourcing model should be used, rather than relying on a one-size-fits-all approach or country-specific decision-making.
The model of the future is more agile and resilient with FSO and FSP concepts applied in a more bespoke and interoperable manner. This agility allows for selecting an operational model that will achieve the lowest cost and accelerated timelines based on specific criteria such as therapeutic area, geography, technology, and site relationships.
The resilience of the outsourcing strategy is the more challenging lever to manage and is strongly driving the transformation we are experiencing. Resilience is based on recognizing a true paradigm shift from managing change to embracing change. The drug development industry is on the cusp of a period of innovation, and success will come to those who are most efficiently able to recognize and implement this innovation. The goal is to build a scalable and efficient framework capable of adjusting to future challenges and opportunities.
Conclusion
The challenges and opportunities facing the clinical development industry are imminent. Evolving the outsourcing model and strategies is key to achieving greatness in this rapidly changing landscape. The future lies in a more flexible, tailored approach to outsourcing that can adapt to the specific needs of each study, function, and geographic location.
To succeed, organizations must:
- Develop structured decision-making criteria for selecting the most appropriate outsourcing model.
- Embrace agility in their operational models to achieve optimal cost and timelines.
- Build resilience by fostering a culture that embraces change and efficiently implements innovations.
- Invest in developing the skills and technologies needed for the future of clinical development.
- Continuously evaluate and adjust their outsourcing strategies to meet evolving industry needs.
By adopting these principles, pharmaceutical companies and CROs can create a more effective, efficient, and innovative clinical development ecosystem that is better equipped to meet the challenges of tomorrow and accelerate the delivery of life-changing therapies to patients.
Author Details
Jenny Denney- Executive Vice President and Head of FSP Clinical Biometrics, Parexel
Publication Details
This article appeared in Pharmaceutical Outsourcing:Vol. 25, No.4 Oct/Nov/Dec 2024Pages: 20-21