How to Optimize Drug Development by Combining FSO and FSP Models
Outsourcing clinical trials has changed significantly in recent years. Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster. But, to recognize these benefits, biotechnology and biopharmaceutical organizations need to understand how to best leverage FSO and FSP outsourcing models.
Our FSP Outsourcing Trends Report show that, in 2018, market utilization of full-service outsourcing (FSO) was at 72%, with usage of functional service partnership (FSP) models lagging at 28%. But over the span of just three years, outsourcing trends have shifted to a more even mix of 59% FSO and 41% FSP.
The report also shows increased utilization of FSPs by 80% of sponsors in 2021 — a significant jump from only 50% reporting the same in 2019.
FSPs have gained traction as sponsors recognize advantages in flexibility and efficiencies, as this outsourcing model accommodates support ranging from filling small gaps in service to large-scale projects. Still, questions often remain.
- What’s the right mix of FSO to FSP engagement?
- How does that mix evolve across projects to meet resourcing needs?
- What’s the best way to combine outsourcing models to drive resource and time efficiencies?
More and more, clients now recognize that the choice is not simply one model over the other. Hybrid approaches that combine FSO and FSP — mixing and matching features customized to your project needs — can offer the best of both models.
It’s important to understand the differences between FSO and FSP solution models for outsourcing clinical trials and how best to combine approaches for optimization.
Core Features of FSO and FSP Outsourcing Models
|FSO: Full-Service Outsourcing||FSP: Functional Service Partnership (Functional Service Provider)|
|Typically awarded on a study or protocol basis, in which the clinical research organization (CRO) partner provides end-to-end services across the entire spectrum of clinical trial services, from study startup, data management and clinical monitoring, to drug safety, regulatory strategies, post-approval monitoring and beyond.||Awarded by specific function, in which a CRO could provide single or multiple services, such as site monitoring, data management, post-approval monitoring or clinical supply services, across numerous protocols.|
|Most often done using the vendor’s systems and standard operating procedures (SOP).||Often working directly within client’s systems and SOPs.|
|Overseen by a CRO project manager.||Overseen by an insourced project manager.|
|Contracts are milestone- or unit-based.||Contracts are full-time equivalent (FTE) or unit-based.|
Examples of Hybrid Outsourcing Strategies for Clinical Trials
For biotech and biopharmaceutical organizations, a strong CRO partner with broad experience in both FSO and FSP engagements is necessary to guide the right mix of service models to use. Ideal partners offer flexibility and work collaboratively to tailor solutions to customers’ specific needs.
The PPD clinical research business of Thermo Fisher Scientific works with customers across the spectrum on developing and implementing appropriate outsourcing strategies. Examples include:
- Determining whether to use FSO or FSP models based on geography
- Combining FSP and FSO models based on therapeutic area, services and clinical trial phase
- Incorporating FSP resources into FSO studies when specific key roles (e.g. project managers, CRAs, statisticians or medics) or study components are desired
Informed Outsourcing Solution Decisions
When drug developers leverage multiple outsourcing models, they also gain the additional advantage of tracking key performance indicators (KPIs) and key quality indicators (KQIs) across models. Visibility of this comparative data within a collaborative CRO partnership enables:
- Informed decision-making
- Optimization of strengths
- Process improvements
One additional consideration is the level of talent you’ll have access to, irrespective of the chosen outsourcing model. As the industry fully embraces hybrid models, it’s key to work with a partner that has extensive breadth and depth of therapeutic and functional expertise in both FSO and FSP models. PPD’s expert talent pool delivers customers the highest-quality expertise, with the knowledge and experience of working within various models and integrating as extensions of internal teams.
The Benefits of Working with an Experienced Partner as Your Functional Service Provider
Strategically selecting the right outsourcing model can bend the cost and time curve of drug development by achieving economies of scale and optimizing resourcing.
Through many years of partnership with clients, including more than 25 years of FSP experience, PPD experts understand that the optimal outsourcing model varies by project. Solutions must be tailored to each sponsor’s needs, scope and individual studies.
That’s why PPD approaches each engagement with the agility and strategy to flex the outsourcing model and meet the individual requirements of each client. Our FSP solutions provide access to customizable and reliable options to support key functional areas, fill gaps in internal capabilities or enhance functional expertise — enabling you to achieve success with your project.