Blending Models for Better Sourcing Solutions

In the new age of sourcing, sponsors are looking beyond the conventional outsourcing or insourcing categories, collaborating with clinical research organizations (CROs) on bespoke solutions that deliver on their unique needs. There is a growing trend among large and midsize pharma in turning toward more strategic partnerships to help them navigate the increasing complexity of the development landscape and the compounding macroeconomic constraints.

Pharma is reassessing their outsourcing requirements to make the most of the models they use. This emphasis on strategically collaborative, flexible partnerships has led to more purposeful variation of the conventional full-service outsourcing (FSO) and functional service provision (FSP) categories, resulting in the adoption of blended solutions.

Moving towards a blended model

Both FSO and FSP have their advantages and limitations depending on the sponsor’s overarching business goals and the unique needs of a clinical trial. FSP has gained traction across the industry, with slightly higher adoption among large pharma,¹ and this model has become a starting point for the elaboration of outsourcing relationships beginning with a branch into embedded FSP as part of the ‘functional continuum.’²

Large pharma sponsors show a rising demand for both FSP and FSO services simultaneously, in an interoperable infrastructure, to harness the best elements of both to create a customized solution optimized to meet their needs. They increasingly seek to retain in-house core competencies in specific functions, commonly supported by FSP, whilst simultaneously identifying tasks that would be better served leveraging CRO infrastructure in a combined blended solution.

Bespoke solutions

The goal of a blended model is a truly custom solution that supports strategic partnership and flexes to fit the immediate and long-term needs of the sponsor. It can be optimally individuated, blending the advantages of FSO and FSP to accommodate the risk/accountability division between sponsor and CRO and/or the type of contracting services utilized, for example, unit-based, deliverables, or outcomes versus full-time equivalent models. This level of agility within an outsourcing model allows sponsors to bend and blend multiple models throughout their portfolio to support deeper innovation and collaboration.

Configuring fit-for-purpose solutions that align with the strategic objectives of the sponsor organization (i.e., cost efficiencies, increased utilization) means the models will vary based on company size, therapeutic areas and geographies. However, common sponsor needs guiding blended solutions include:

• Control and accountability
• Flexibility and scalability
• Cost efficiency
• Speed to market
• Risk management

New roadmaps for efficient outsourcing

The customization and flexibility of a blended outsourcing approach allows different models, or versions of models, to be deployed across the CRO-sponsor partnership. Large and midsize pharma will have different patterns of configuration but will largely seek the same ultimate benefits to development. While there is unlimited possibility for variation, there are three general categories that serve as a roadmap for blended model implementation:

Strategic or functional – Clinical FSP or FSO services expanding to include tactical FSO, FSP, or standalone services to complement delivery. This often begins with FSP services growing functionally, i.e., regulatory, data management, biostatistics, pharmacovigilance and medical writing, and then expanding to FSO services like labs or early-phase with strategic geographical support.

Enterprise – An alliance partnership where resources are seamlessly migrated across model types (FSO, FSP, standalone, or specialty) to improve efficiency. Enterprise-level partnership governance enables portfolio review to strategically reduce spend and increase direct control.

Transformative – A flexible model where the sponsor directs the configuration of the model depending on the amount of control required over core/non-core assets to support their objectives, especially during strategy transitions.

Realizing the benefits of blended

Strategic partnerships with CROs enable pharma to maximize the value of custom outsourcing. Sponsors benefit from a single point of contact for seamless service coordination, while joint oversight and a formal governance framework ensure accountability and prompt decision-making. Larger CROs may offer a dedicated business unit structure, simplifying communication and aligning objectives with the sponsor’s strategy.

Enhanced flexibility and scalability support efficient resource allocation, enabling easy expansion into new regions and synchronization between the trial portfolio and workforce. This agile control allows sponsors to adapt to trial or market challenges to minimize risk along with enhanced transparency and collaboration. Ultimately, the efficiencies within the model facilitate tangible benefits within development programs, including accelerated site cycle times, improved patient recruitment and reduced costs.

To achieve these benefits, sponsors should consider these foundational elements for success:

Support – Strategic alliances rise and fall on the ability of both partners to unite around a shared vision for progress. Securing the appropriate buy-in and cultural alignment is vital for sponsors to drive constructive engagement in blended models.

Scope – Changes to outsourcing must be considered as part of the wider system to ensure a maximum return on investment. For example, changes to operating practices, lines of communication, role descriptions and headcount distribution are important enablers of success.

Scale – While the overall size of the undertaking determines certain economies of scale, the proportion of a function that is migrated to a hybrid FSP or blended model also influences the overall potential for efficiency gains.

It takes two

As with any outsourcing model, the partnership can make or break it. However, blended models place additional emphasis on partnership and cultural alignment to operate effectively. The right partner will provide the complementary solutions, services, and infrastructure to progress sponsor programs and supporting the sponsor’s strategic control over their portfolio. CROs with robust internal systems designed to work seamlessly within sponsor systems or technology will provide the flexibility to suit sponsor goals.

As they reassess their outsourcing needs, sponsors will benefit from a trusted, collaborative partnership with a CRO to deliver optimized program or enterprise-level operations. When thoughtfully implemented, blended models provide the accountability and control, flexibility and scalability, and time and cost-efficiency.

Tony Southers, Executive Vice President, Head of ICON Strategic Solutions

References

1. Industry Standard Research, 2021. Clinical Development Outsourcing Models.
2. Getz, K.; Shah, S.; Luithle, J.; Travers, M. Redefining CRO sourcing model terminology to optimize outsourcing strategies. Applied Clinical Trials. Published online September 20, 2022. https://www.appliedclinicaltrialsonline.com/view/redefining-cro-sourcing-model-terminology-to-optimize-outsourcing-strategies. Accessed Aug 3, 2023.