Beyond FSP vs Full-Service: Building the Right Operating Model for Accelerated Drug Development?

Drug development is accelerating. Is your operating model keeping pace?

Across the industry, sponsors face increasing protocol complexity, cost pressure, talent constraints and heightened expectations from regulators, investors and patients. The pressure to bring therapies to patients faster has never been greater. At the same time, regulatory agencies are exploring new approaches that may support more efficient development pathways.

This year has brought growing U.S. regulatory flexibility around single pivotal trials, where FDA revised draft guidance clarifies how one adequate and well-controlled clinical investigation with confirmatory evidence may satisfy the substantial evidence standard in appropriate circumstances¹. In parallel, real-time and accelerated clinical trial review approaches are emerging in both the U.S. and China^2,3. FDA's Real-Time Oncology Review program supports earlier submission of selected efficacy and safety results before the complete application is submitted², while China's National Medical Products Administration has announced a 30-working-day review and approval pathway for eligible innovative drug clinical trial applications³. In Europe, the proposed European Biotech Act aims to strengthen and streamline the regulatory environment in areas such as clinical trials and cell and gene therapies⁴.

For sponsors, the implication is clear: development strategies must become more agile, integrated and resilient. Yet many organizations are still approaching one of the most important strategic questions in drug development through an outdated lens: Should we choose FSP or full-service outsourcing?

That question no longer reflects the reality of modern development. As clinical programs become increasingly dynamic, outsourcing decisions are evolving from procurement exercises into strategic operating model decisions. Sponsors are seeking delivery approaches that provide flexibility, continuity, specialist capabilities and accountability while allowing them to retain control where it matters most. The strongest strategies increasingly combine regulatory insight, operational planning and scalable delivery models that can adapt as portfolio needs evolve.

Why should regulatory strategy come before delivery model selection?

One of the most common challenges in outsourcing discussions is that the delivery model conversation often began before the development strategy has been fully defined.

A more effective approach is to reverse that sequence. Before selecting an outsourcing model, sponsors should first understand the optimal development pathway for the asset, the regulatory milestones that must be achieved, priority countries and regions, potential future indications, key execution risks and the capabilities most critical to long-term success.

Regulatory strategy plays a pivotal role in shaping these decisions. Early regulatory input can influence protocol design, submission planning, country strategy, resource forecasting and governance requirements. These decisions subsequently influence the type of operational support required and the most appropriate delivery model.

Organizations that align regulatory and operational planning early in development are often better positioned to avoid rework, anticipate challenges and maintain program momentum.

"The outsourcing conversation often starts too late and too narrowly. Before deciding how work will be delivered, sponsors should first understand the optimal development pathway for the asset, the regulatory expectations they are likely to encounter and the operational risks that could affect timelines. The delivery model should support those decisions, not drive them." 

- Alicia Baker, Vice President and Head of Regulatory Consulting, Fortrea

5 questions sponsors should ask before selecting an outsourcing model

Instead of starting with a preference for FSP or full-service delivery, sponsors may benefit from asking five strategic questions:

1. What is the optimal development pathway for the asset?
Consider development goals, regulatory requirements, commercial ambitions and geographic priorities.

2. Where are the greatest regulatory and execution risks?
Identify areas where specialist support, additional oversight or enhanced governance may be required.

3. Where is sponsor control most important?
Determine which activities should remain closely managed internally and where external support can create value.

4. Where is additional capacity and/or specialist experience needed?
Evaluate current resource availability across key functions and identify areas where scalability may be required. Evaluate potential experience gaps requiring external support.

5. How much flexibility will the portfolio require over time?
Consider future studies, indication expansion, geographic growth and changing funding or resource demands.

These questions shift the conversation away from model labels and toward strategic business outcomes.

From model selection to model optimization: the portfolio-led operating model

Historically, sponsors approached outsourcing as a binary choice: retain functional control through an FSP model, or transfer broader delivery accountability through a full-service arrangement. That distinction rarely captures today’s reality. Clinical portfolios are not static, and different assets often require different operating models at the same time - full-service for a complex global Phase III, targeted FSP for an established regional study, and specialist regulatory or data capability for an early-stage asset.

Across BioPharma we increasingly see FSP and full-service requests converging, as sponsors seek approaches that combine strategic oversight with scalable external support. The most progressive sponsors no longer evaluate models on cost alone; they assess how effectively each supports portfolio agility, operational resilience, risk management and development speed.

In our view, the FSP-versus-full-service question is the wrong one to optimize around. A true strategic CRO partner should not ask the sponsor to pick a lane; it should engineer a single, adaptive, portfolio-based delivery engine that combines the control and embedded ownership of FSP with the scale and execution power of full-service - removing the traditional trade-off rather than passing it back to the sponsor. Delivering on that requires four integrated components working together:

1. Centralized delivery driving efficiency, consistency and scalability 
2. Multi-functional resource pods for rapid execution and continuity, with no re-onboarding 
3. Targeted dedicated resources - embedded roles for critical, high-risk activities where ownership, stability and control matter most
4. Flexible specialist capacity - overflow and advanced support for complex or acquired portfolios.

The CRO’s role is to make these components flex dynamically across the portfolio - based on study complexity, portfolio priority, risk profile and the level of sponsor oversight required - so the conversation shifts from model selection (FSP vs. full-service) to model optimization (best-fit delivery). Done well, a sponsor can run different models against different assets simultaneously: full-service for a global pivotal program, FSP for monitoring or data management across a therapeutic area, and targeted regulatory or specialist support for a specific milestone. That is the standard a strategic partner should hold itself to — orchestrating the right mix for your needs, not handing you a menu of services.

"Sponsors are increasingly moving beyond study-level thinking and building outsourcing strategies through the lens of their broader portfolios, development stages and future scenarios. That requires flexible access to capability, continuity of institutional knowledge and delivery structures that can evolve alongside changing priorities."

- Petko Baltov, Head of Clinical FSP, Fortrea

The outsourcing model follows the asset's risk and value profile

A further shift in outsourcing trends is that the preferred model increasingly follows the risk and value profile of the asset, rather than company policy. High-risk or accelerated assets pull toward embedded ownership and senior oversight; mature or repeatable work moves to centralized, activity-based delivery - often within the same portfolio, at the same time.

The two use cases which we highlight here have the same commonality: high-risk, time-critical assets were given embedded ownership, while repeatable work moved to standardized, activity-based delivery - different models applied concurrently across one portfolio according to each asset’s risk profile. That is the operational embodiment of “model follows risk.”

From model preference to model intelligence

There is no universally correct outsourcing model. The right approach depends on the asset, the portfolio, the regulatory pathway, the organization's internal capabilities and the development challenge it is trying to solve. 

As development timelines compress and program complexity grows, sponsors need delivery strategies that can adapt without sacrificing quality, governance or accountability. 

The most effective approaches begin with the development objective, integrate regulatory and operational planning, anticipate future portfolio needs and apply the most appropriate delivery model at the right moment. 

The differentiator is no longer the model itself. It is the ability to adapt with confidence. 

That is where modern outsourcing is heading: from model preference to model intelligence, from static structures to adaptable delivery strategies, and from isolated resourcing decisions to integrated development planning.

Want to know more about how our team can help accelerate your business, contact us to set up a call.

FAQs

Q. What is the difference between FSP and full-service outsourcing? 
A. FSP typically gives sponsors access to functional support while retaining greater control over your projects. Full-service outsourcing transfers broader operational delivery accountability to an external organization. Many sponsors now use blended models that combine elements of both.

Q. Why is regulatory strategy important when choosing an outsourcing model?
A. Regulatory strategy shapes the clinical development pathway for an asset, and influences study design, country selection, submission planning, resource needs and execution risk. When regulatory planning happens early, the delivery model can be shaped to support the asset strategy rather than forcing the asset into a predefined operating structure.

Q. What is a hybrid clinical trial outsourcing model?
A. A hybrid outsourcing model combines different delivery approaches across assets, functions or development stages. For example, a sponsor may use full-service delivery for one study, FSP support for specific functions across a Therapeutic Area or their broader portfolio and targeted regulatory or data capabilities for a specific development milestone.

Q. How can sponsors choose the right clinical trial delivery model?
A. Sponsors can start by defining the development pathway, regulatory risks, required level of sponsor control, capacity gaps and likely portfolio changes. Those factors can then guide whether FSP, full-service or a blended delivery model is most appropriate.

References

1. U.S. Food and Drug Administration. Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products: Draft Guidance for Industry. FDA; June 2026. Last accessed August 19, 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/demonstrating-substantial-evidence-effectiveness-human-drug-and-biological-products 
2. U.S. Food and Drug Administration. Real-Time Oncology Review. FDA Oncology Center of Excellence. Updated November 18, 2024. Last accessed August 19, 2026. https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review
3. National Medical Products Administration. Announcement on Optimizing of the Review and Approval Process for Clinical Trials of Innovative Drugs ([2025] No. 86). National Medical Products Administration; September 9, 2025. Last accessed August 19, 2026. https://english.nmpa.gov.cn/2025-10/14/c_1132769.htm
4. European Commission. European Biotech Act. Public Health. Last accessed August 19, 2026. https://health.ec.europa.eu/biotechnology/european-biotech-act_en