Clinical Research Outsourcing Solutions
The right outsourcing solution for the moment you’re in—and for what comes next
Clinical research doesn’t follow a straight path. Instead, it’s a winding road of changing priorities, fluctuating demands and emerging challenges. A key concern among sponsors is finding a clinical research solution that keeps up with inevitable changes.
Can your outsourcing solution keep pace with your evolving needs?
Drug development is becoming increasingly complex, with sponsors facing mounting pressure around timelines and costs, and navigating operational, scientific and data challenges.
A single day of delay is worth approximately $500,000 in unrealized/lost prescription drug sales and $40,000 in direct daily clinical trial costs1
The average phase III protocol collects 5.9 million datapoints, up 11% annually since 20202
The average research and development cost to develop a new drug has increased by 65% in the last 10 years, rising from $1.3 billion to $2.2 billion3
Tailored partnerships that drive confident progress
Sponsors need a clinical research partner that cuts through complexity. But success requires more than solutions alone. It requires a partnership tailored to sponsors’ needs, providing the right balance of control, flexibility and adaptability to keep pace with evolving demands at every stage of clinical development.
With more than 30 years of experience, the PPD™ clinical research business of Thermo Fisher Scientific reliably delivers tailored solutions to meet the moment you’re in and advance what comes next. We partner with a wide range of sponsors, from the world’s top pharmaceutical companies to fast-paced, innovative biotech firms, and beyond.
Our reliable and flexible bespoke outsourcing solutions cut through complexity and solve operational, scientific and data challenges, while complementing your capabilities, leveraging your strengths and driving confident progress.
Less friction. More predictable execution. Faster progress.
Our bespoke solutions, adapted to your needs
Full-service outsourcing (FSO) arrangements
Our FSO arrangements are ideal for sponsors who lack specific study-related expertise or the resources necessary to execute the trial themselves.
They involve the complete, end-to-end outsourcing of clinical trial tasks (from study startup through database lock) established on a study or protocol basis, and leverage the full depth of our capabilities, as needed, to support trials at any phase, from early development through Phase II and III and into peri- and post-approval.
Contracts are usually milestone- or unit-based. Activities are conducted using our standard operating procedures (SOPs) and platforms.
Functional service provider (FSP) partnerships
Our FSP partnerships are ideal for sponsors who want closer control and visibility of clinical development operations and have the infrastructure to assume greater management responsibility.
Our FSP solutions provide support for a specific function or functions across protocols, medicinal products, a portfolio of studies, or a company. It also helps sponsors expand their capabilities or capacity using top-tier talent, while also leveraging their own internal strengths and capabilities.
Contracts are typically allotted by function rather than by study and use cost models based on full-time equivalents (FTEs), units, or time and materials.
In the FTE model, personnel often work directly within a sponsor’s existing standard operating procedures (SOPs) and platforms.
Mixed FSP/FSO model solutions
Our mixed FSP/FSO model solutions are ideal for sponsors who want greater control of a critical or strategically important clinical development function or need additional resources or specific capabilities to meet unexpected demands and keep projects on time and on budget.
Mixed FSP/FSO model solutions combine FSP and FSO models to create bespoke solutions to meet specific customer needs. These arrangements often include single or multiple FSP offerings added to an existing FSO arrangement on an as-needed basis (or combined from the start to create a custom solution).
These models may also bridge the transition period when shifting from FSO to FSP outsourcing.
They may be delivered from one or multiple CROs; be established by protocol, portfolio of studies, or company; and provide support on both short- and long-term timelines.
These models use your systems and SOPs, our systems and SOPs, or a combination of the two, and may be executed through a single or mixed cost model.
Our expertise, by the numbers
Years of clinical and scientific leadership
Employees across the globe
Studies in the past five years
Real-world and market access engagements in the past five years
Expert insights to inform your tailored outsourcing model solution needs
A full spectrum of flexible, tailored outsourcing solutions
FAQs
These solutions provide a customized mix of expertise, resources and support to help you navigate increasing clinical development complexity at every stage of the drug development lifecycle.
These solutions align with your specific needs, giving you control when you want it, and the adaptability to meet ever-changing clinical development demands when you need it, while maximizing flexibility, control, and efficiency. And through customized models, they provide the exact expertise, resources and support you need to solve operational, scientific and data challenges to meet your goals.
When selecting a provider, you should focus on a partner that adapts to and keeps pace with change as clinical development needs evolve. Whether you require end-to-end trial management, support for a specific function, or a customized combination of services, your partner should provide the flexibility to deliver bespoke solutions specifically tailored to your goals, requirements and internal capabilities. The ideal partner should offer the ability to scale resources, provide access to specialized expertise and adjust support as priorities shift, ensuring the solution remains aligned with both current and future needs.
Sponsors should also seek partners with deep clinical, therapeutic, operational and functional expertise, supported by a consultative approach and access to global talent. Proven experience, reliable execution and the ability to deliver measurable results are key indicators of a strong partner. The ideal partner will also reduce operational friction, improve predictability and accelerate study progress through established processes, scalable infrastructure and a track record of supporting successful clinical development programs.
These solutions drive success by aligning clinical research support with a sponsor’s unique goals, capabilities and operational requirements. Since no two organizations face the same challenges, the most effective solutions are customized to complement existing strengths, fill capability gaps and provide the exact expertise, resources and oversight needed.
By customizing FSO, FSP or mixed FSP/FSO model solutions, sponsors maintain the right balance of flexibility, control and support while adapting to changing clinical development demands. A customized approach enables sponsors to navigate increasing trial complexity with greater efficiency and predictability. It results in less friction, more predictable execution and faster progress.
Our PPD clinical research business offers tailored solutions that complement your capabilities, leverage your strengths and address your evolving needs. With more than three decades of experience, we are uniquely positioned to build innovative FSO, FSP and mixed FSP/FSO model solutions that maximize flexibility, control, and efficiency. We combine a consultative approach, deep clinical, therapeutic, and functional expertise, scalable global talent, and the full spectrum of Thermo Fisher Scientific’s capabilities to create and provide bespoke solutions that deliver with less friction, more predictable execution and faster progress.
Our partnerships extend well beyond staffing arrangements and cost structures. We are committed to serving as an extension of your organization, aligned with your culture and aspirations. We know the most successful partnerships are built on shared commitment, where collaboration fosters a sense of ownership and empowerment on both sides.
With this approach, our staff become more than just resources; they become an integral part of your team, contributing their knowledge and insights, bringing fresh perspectives and implementing innovative strategies that support your goals and timelines. With the right partner in place, sponsors move forward with confidence, with the right solution keeping their clinical trials on track for the moment they’re in, while at the same time, building a more resilient clinical development ecosystem for what comes next.
More than a model—a partnership
Our PPD clinical research business serves as an extension of your team, aligning with your culture, goals and ways of working to create a partnership built on shared ownership, strategic expertise and operational agility. Beyond providing resources, we bring fresh perspectives and specialized knowledge that accelerate execution and support confident decision-making.
By combining our expertise with your strengths, together we navigate complexity, maintain momentum and keep your clinical development programs on schedule. As a result, you’re able to move forward with confidence, knowing that your tailored outsourcing solution will keep your trials on track for the moment they’re in, while also building a more resilient clinical development ecosystem for what’s to come.
Discover the right solution to meet the moment you’re in—and for what comes next. Let's connect.
- How much does a day of delay in a clinical trial really cost?, June 2024, Applied Clinical Trials, Ken Getz, Executive Director and Professor, Tufts University School of Medicine
- Insights Informing Strategies for Optimizing the Collection of Clinical Trial Data | Therapeutic Innovation & Regulatory Science | Springer Nature Link
- Deloitte, Measuring the return from pharmaceutical innovation, 15th edition March 2025