The Power of Bespoke Hybrid FSP/FSO Solutions

Clinical trial sponsors that utilize full-service outsourcing are finding more and more reasons to add FSP solutions into the mix, creating customized hybrid solutions that are better suited to a wide range of needs.

One interesting trend emerging from the 2023 Pulse Report is the rise of hybrid functional service provider (FSP)/full-service outsourcing (FSO) arrangements. In that survey of 150 leaders in biotech and biopharma, 87% of participants reported using FSP or hybrid FSP/FSO outsourcing. Each model delivers a distinct set of capabilities to the study sponsor:

• In an FSP arrangement, the contract research organization (CRO) performs a specific function or multiple functions (clinical operations, pharmacovigilance, etc.) across protocols, medicinal products, a portfolio of studies or the entire company.
• With FSO, all clinical trial tasks (study startup, data management, clinical monitoring, pharmacovigilance, regulatory affairs, etc.) are outsourced to the CRO.

Increasingly, sponsors are looking for a hybrid approach that combines FSP and FSO models in a bespoke solution that maximizes clinical trial performance. In a hybrid model, single or multiple FSP offerings can be added to an existing FSO arrangement to optimize their clinical trial operations and address unanticipated or changing demands. These bespoke hybrid arrangements are very flexible: They can be delivered from one CRO or multiple CROs; they can be established by study, protocol, portfolio or company; and they can support any given time scale and any combination of systems and standard operating procedures (SOPs).

Common use cases for hybrid solutions include:

• Supporting an existing FSO arrangement with additional expertise or resources to support a specific study function
• Supporting a sponsor that requires clinical development resources to expand into areas that lack sufficient demand for an FSO arrangement
• Delivering specific needs that cannot be met by an FSO arrangement alone, such as expansion into new regions, new therapeutic areas and new trial phases
• Maintaining greater control over critical or strategically important clinical development functions.
• Ensuring consistent product/program knowledge across a portfolio
• Quickly scaling resources or specific capabilities to keep projects on time and on budget in the face of unexpected demand
• Maintaining continuity — including critical staffing continuity — during business disruption
• Mitigating risk by avoiding use of a single outsourcing provider for all clinical development functions
• Facilitating a smooth transition from an existing FSO deployment to a new FSP engagement

These and other real-world use cases for hybrid FSP/FSO solutions are as varied and unique as the drug and device developers that utilize them. Often, however, a hybrid use case will fit into one of these general categories:

1) An existing FSO arrangement needs additional expertise or resources to support a specific study function, requiring the developer to scale or augment that FSO arrangement with FSP services. When outsourcing some or all key functions to an FSP provider, a drug developer gains access to a wider pool of talent, including specialized functional, scientific and technical experts. Our PPD™ FSP solutions, for example, combine the agility of the traditional FSP provider with the deep internal talent pool that is the hallmark of the FSO arrangement to help sponsors quickly fill gaps and scale resources up or down according to need. As a result, developers that leverage our FSP solutions have immediate access to a well-vetted workforce that can be mobilized rapidly, in addition to the option to seek externally recruited experts to staff unfilled positions.

2) An established FSO arrangement is to be replaced, and the developer needs to transition to FSP without disrupting momentum. For a developer using an FSO model but looking to evolve the way they undertake clinical trials, a bespoke FSP/FSO hybrid solution can provide a smooth transition to FSP outsourcing. For example, a company bringing its first gene therapy candidate to market but lacking key expertise in running a gene therapy trial can start with an FSO model and transition to FSP arrangements as their internal expertise and experience grows. This approach enables unbroken continuity of support and resources across clinical trial operations.

3) An entirely new FSP arrangement is needed, and the developer wants to work with an existing FSO partner. When a sponsor is satisfied with a well-run FSO arrangement, it may seek to implement a separate FSP engagement with the same CRO. For example, a sponsor may engage with the existing CRO for a new FSP clinical data management solution and launch the engagement with a dedicated implementation phase that enables setup of database standards, communication tools and ways of working before moving into the study delivery phase. In this case, a hybrid FSP/FSO model allows the sponsor to continue its existing relationship and maintain business familiarity through governance meetings for both the FSO and FSP engagements and joint operating committees covering both arrangements.

Partner with an FSP provider that delivers results across every use case

Drug developers count on strategic collaborations for success, and those collaborations come in many forms. For developers that deploy FSO arrangements to outsource clinical trial tasks, the additional incorporation of an innovative FSP solution can meet the needs of a wide range of use cases and can play a key role in on-time, on-budget delivery.

Our PPD FSP solutions help biotech and biopharmaceutical companies meet their timelines by providing top-tier functional expertise that complements existing capabilities and helps companies tackle their unique clinical development challenges.

With more than 25 years of experience, we know what it takes to deliver customized solutions tailored to the unique needs of each client, providing much-needed resource flexibility, reliability and continuity. Our PPD FSP solutions have supported nearly 300 clients, including nine out of 10 top pharma organizations over the past five years, with bespoke recruiting strategies and dedicated roles that ensure rapid mobilization, coordinate necessary training and maintain constant communication. Our extensive portfolio of PPD FSP solutions provides experts who deliver a breadth and depth of therapeutic and functional expertise unmatched in the industry, uniquely positioning us to deliver the right experience and knowledge to fill immediate resource gaps or outsource multiple functions across a portfolio.