Meet Your Timelines with PPD Functional Service Partnership (FSP) Solutions
PPD FSP solutions deliver the top-tier expertise you want and the on-time delivery you need
The pharmaceutical industry is constantly in motion — drug patents expire, new therapies emerge, portfolios expand, and life-changing compounds make their way to market. And increased costs, trial complexity and extended timelines are continuing to put greater burdens on sponsors, sites and patients. As a result, it’s critical for drug developers to engage a partner that can navigate these challenges and predict and manage the resources and capabilities needed for projects to be successful.
That’s why more companies are turning to functional service providers (FSP) for their outsourcing needs. FSP services help you advance your next drug development project — whether you need to fill small gaps in services or support large-scale programs with dedicated capacity management across multiple functions. FSP models, and mixed models that combine elements of FSP and full-service outsourcing (FSO) to create bespoke client solutions, also increase flexibility and provide access to the exact expertise your project needs, when you need it, in just the right amount.
With more than 30 years of experience across more than 160 countries, PPD™ Functional Service Partnership (FSP) solutions help biotech and biopharmaceutical companies meet their timelines by delivering the best of the best: hard-to-find, top-tier staff with a proven track record of reliably delivering clinical development and post marketing services.
Discover the latest utilization and growth projection of FSP partnerships
Explore how a FSP model is the leading strategy for biotech companies to meet their timelines
Expand your clinical trial capabilities with a hybrid outsourcing model combining elements of FSP and FSO arrangements
Delivering the right expertise for every FSP engagement
Because you can’t always predict — or find and retain — the staff and services you need, our experts deliver an unmatched breadth and depth of expertise, uniquely positioning us to provide the right experience and knowledge to fill immediate clinical development resource and capability gaps.
PPD FSP solutions provide access to a wide range of reliable and customizable resources to support key functional areas, fill gaps in internal capabilities or enhance functional expertise – all backed by the full force of our global infrastructure, training, resources, and expertise – and delivered with an uncompromising commitment to quality.
With the ease of a single partner, we provide operational, functional, technical, and therapeutic specialists across all phases and therapeutic areas at all levels, including senior roles. We help solve your resource challenges and provide support for clinical and marketed products across every aspect of a drug development program.
We position biotech and pharmaceutical companies for success.
expert research professionals
years of FSP experience
customers supported to meet their milestones
countries with our FSP capabilities
Accelerate the next generation of life-changing therapies
Explore the growth and utilization of FSP arrangements, the innovative future of these models, and the keys to successfully leverage them.
Learn how our top-tier clinical development experts can help power your next big discovery
Bespoke talent delivery and development strategies deliver top-tier professionals
Two-pronged approach to talent delivery
For a successful FSP engagement, maintaining a pool of top-tier professionals is critical in a hyper-competitive talent market. PPD FSP solutions employs a bespoke talent delivery strategy for FSP engagements that combines the advantages of traditional full-service outsourcing and FSP recruitment models.
We employ an innovative two-pronged approach to staffing: drawing from our internal pool of skilled staff, and using proactive, external recruiting methods to continually hire hard-to-find talent. With dedicated recruiters, well-established rapid identification, interview, and selection processes, and frequent reporting, we ensure accountability, requisition ownership, and quick and efficient talent delivery, ultimately improving efficiency and decreasing ramp-up timelines.
Remote-based regional hubs resources
Another approach that sets PPD FSP solutions apart from other contract research organizations (CROs) is our global resource hubs staffing model. Our remote-based regional hubs provide a geographically distributed and predominantly remote workforce (rather than standard brick-and-mortar office setups in select major cities) that expands talent pools and identifies the best-suited and most cost-effective professionals for the job—wherever they are.
Our five remote-based regional hubs in Latin America, India, China, Central and Eastern Europe, and the Philippines are led by dedicated leaders who understand the local culture and regulations and have extensive regional knowledge and expertise. And while traditional training focuses on specific functions, our remote-based regional hubs prioritize cross-training across logical functional combinations, delivering sourcing flexibility while providing our staff with continuous professional and career development that enhances their capabilities and engagement.
Ongoing talent development
Developing a reliable deep bench of experts across our organization also demands innovative training approaches, including upskilling and reskilling to train for future needs. For FSP engagements, our FSP Academy delivers a series of training modules that provide information, guidance, and best practices for managing the unique aspects and nuances of delivering FSP solutions. Continued employee development and education also occurs regularly to enhance skills and nurture well-rounded, long-term research professionals. This includes ongoing development of soft skills to help FSP staff improve their ability to communicate, negotiate, and handle conflicts and fostering an environment where all parties feel comfortable having open and transparent conversations, addressing challenges head on, and seeking solutions together to cultivate partnerships that address and resolve challenges before they escalate, putting timelines at risk.
Our industry-leading training of site-facing roles—and our focus on ensuring cultural alignment when deploying resources—also helps our clients become the sponsor of choice. Great communication is our strength—our staff are adept at listening to sites and patients, putting themselves into their shoes to address their specific challenges, and overall, demonstrating true site and patient centricity. In turn, this translates into deeper engagement, better collaboration, improved experiences for patients, sites, and sponsors, and greater likelihood of meeting timelines.
Our commitment to professional development and learning culture makes us a great company to work for – and is why we deliver consistent staffing with high engagement, low turnover, and attrition rates far better than industry averages.
Flexible, personalized solutions
It’s important to find the right solutions to your resourcing challenges. With more than three decades of experience, PPD FSP solutions knows what it takes to reliably provide customized solutions tailored to the specific needs of our clients—from meeting the demands of the world’s top pharmaceutical giants to supporting the dynamic fast-paced environments of innovative biotech firms. Our FSP solutions are available across all functions, from clinical services to marketed products, and are available worldwide, for one-off and large-scale projects — and everything in between.
Industry-leading scale
When you need to scale a project, our FSP solutions have the scope to make it happen. Rely on our more than 30,000 research professionals across the globe who can provide you with the support you need, when you need it.
Ease of a single partner
The extensive breadth and depth of our services for clinical trials and marketed products spans all phases, therapeutic areas and levels (including senior roles) in more than 160 countries. This allows PPD FSP solutions to function as a single partner for your projects.
Dedicated roles drive on-time delivery and ongoing support
Through a functional service partnership, our professionals serve as an extension of your teams, supporting key functions that drug development programs can’t afford to leave to chance. Pharmaceutical companies of all sizes and at all phases of drug development need flexible, predictable, reliable and cost-effective options to support their evolving needs, and our FSP solutions deliver.
To ensure a seamless and efficient transition and startup and alleviate the burden on you, we have dedicated roles and well-defined change management processes in place to swiftly identify and deploy staff, maintain open and transparent communication, and proactively problem solve any issues that may arise.
How our dedicated roles work for you:
- Implementation lead (IL): It starts with this role, dedicated to driving seamless onboarding, deployment of resources and establishing our professionals as an extension of your team.
- Operations delivery lead (ODL): This role supports the duration of your FSP engagement. The ODL provides oversight, anticipates and responds to your needs with urgency, and ensures team members have the resources they need.
Throughout our engagement, we establish mutual trust so that accountability is shared, solutions are collaborative, and commitment is rewarded.
Implementation lead
You not only need quality FSP resources and services — you have milestones to reach and timelines to hit. That’s where the implementation lead comes in. This dedicated role focuses on the onboarding of resources so engagements with a significant scope or volume of work begin with a proactive partnership.
With the implementation lead, startup responsibilities usually managed solely by an operations delivery lead are divided to create an additional layer of project oversight that drives better outcomes and more efficient communication.
Through this approach, the implementation lead drives seamless onboarding and proactive customer service – in turn avoiding startup delays, ensuring a smooth transition and meeting timeline commitments.
Operations delivery lead
To establish, maintain and nurture the partnerships forged by the implementation lead, an operations delivery lead is dedicated to your project, serving as a single point of contact that provides oversight and aligns with the you on timelines, strategies and project delivery.
Through ongoing engagement and collaboration, the operations delivery lead provides dedicated, full program oversight, planning, performance management and partnership-building to deliver more responsive communication and drive greater continuity, reliability, productivity and satisfaction.
Ready to meet your timelines?
Delivery models tailored to your needs
Strategically selecting the right outsourcing models can bend the cost and time curve of drug development by maximizing quality, operational success and financial efficiencies.
Flexible engagements to achieve project goals
We partner with each of our clients to personalize the FSP model they need, which includes a flexible mix of systems, processes, oversight and facilities. We can embed our staff within your workforce, tailor deliveries using client systems and processes or take the work fully in-house using our innovations and technologies. We also leverage innovative pricing models to accommodate various contract structures from full-time equivalent (FTE), unit-based, outputs-based, time & materials and mixed FSP and FSO models.
Since meeting your specific needs as they exist at any given moment is key to any FSP relationship, our advanced capacity management planning provides accurate resource forecasting for large-scale relationships to determine when/where staff and services are needed. Proactive planning helps us avoid delays to deliver on time – and on budget – as we scale up and down with the peaks and valleys of your project requirements.
Our large pools of highly skilled resources located throughout our remote-based regional hubs also deliver a broad range of on-demand global staff and services to help you meet your deadlines.
- Leverage follow-the-sun (FTS) models to create around-the-clock productivity by using global teams of resources strategically located across different time zones.
- Expand your clinical research into emerging markets or remote areas with untapped patient populations and research sites with lower clinical trial activity to deliver more consistent enrollment and heightened staff engagement.
- Meet broad and diverse operational requirements—for either local or global engagements— by accessing a wide variety of cost-efficient and reliable professionals.
Expand your clinical research into emerging markets or remote areas with untapped patient populations and research sites with lower clinical trial activity to deliver more consistent enrollment and heightened staff engagement.
Leverage follow-the-sun (FTS) models to create around-the-clock productivity by using global teams of resources strategically located across different time zones.
Meet broad and diverse operational requirements—for either local or global engagements— by accessing a wide variety of cost-efficient and reliable professionals.
Mixed FSP/FSO models customized to client needs
To supplement internal capabilities or provide capabilities that cannot be accommodated by a FSO arrangement alone, FSP services may also be added to new or existing FSO engagements to create a mixed FSP/FSO solution customized to the client’s needs. The innate flexibility of mixed model arrangements makes them ideal options to maximize the performance and efficiency of clinical development programs: they may be delivered from one or multiple CROs; can be established by study, protocol, portfolio, or company; and may provide support when, where, and for as long as needed.
Mixed model engagements are especially effective for responding to unexpected demand or business disruptions, allowing for a rapid scale-up of resources or capabilities to keep projects on track and within budget. Additionally, they enable you to have greater control over critical or strategically important clinical development functions, or when consistent product or program knowledge is needed across a portfolio. Mixed models are also invaluable when clinical development resources are needed to expand into areas that lack sufficient demand for an existing FSO arrangement, such as growth into new regions, therapeutic areas and trial phases.
Regardless of whether we support one or more functions through an FSP-only or mixed FSP/FSO delivery model, our FSP solutions support sponsors’ development of clinical and marketed products with an uncompromising commitment to quality, while providing resource flexibility, reliability and continuity.
Rebadging expertise
In today’s drug development climate, organizations must ensure proper utilization across programs. PPD FSP solutions help you navigate staffing challenges by offering a dedicated staff transfer team focused on change management and business continuity. The staff transfer team:
- shifts costs from direct to indirect to give more flexibility and allow right-sized workforces,
- has expertise in Acquired Rights Directive (ARD) laws and regulations with an 87% average transfer success rate,
- eliminates risks involved in hiring and layoff cycles, and
- condenses vendor contracts to reduce legal, financial and ongoing oversight burden.
PPD FSP solutions
By choosing an experienced, industry-leading functional service provider for one or multiple services to deliver the right experience and knowledge to fill immediate clinical development resource gaps, you gain flexibility and financial efficiencies, allowing you to focus on your areas of expertise.
Biostatistics and programming
Clinical data management
When it comes to clinical trial data management, collaboration across the project teams enables:
- earlier identification of the critical risks to data delivery in a study,
- the design of data capture systems to drive real-time data collection, and
- implementation of processes to minimize errors from being introduced in the data collection process.
Data validations are put in place for all patient data sources, and we coordinate the delivery of data from internal and external sources to support interim and final data deliveries.
Clinical operations
Expert clinical operations professionals ensure accelerated end-to-end study execution through our bespoke solutions. Work with our frontline staff as they conduct on-site monitoring and management throughout the study to oversee data collection, ensure regulatory compliance and resolve data queries.
Feasibility
With clinical trials becoming more complex, there is increased competition for sites and patients, as well as an increased need for insights into study planning for country selection to prevent in startup and study completion delays. Our custom-fit, data-driven feasibility solutions provide a comprehensive analysis of critical study components to best inform and help you across your protocol development journey.
Global clinical supplies
Efficiently navigating logistical processes and global regulations can be challenging for biotech, biopharmaceutical and medical device organizations seeking to manage all aspects of their clinical trial supplies lifecycle. Our Global Clinical Supplies (GCS) solutions apply unique clinical site and patient insights along with the ease of a single partner to optimize and nimbly manage entire clinical supply chains.
Medical writing
Effective communication — with patients, sites and regulatory authorities — is a critical component of any study. Our medical writing team offers agile, expert support to help you communicate with your stakeholders. Pharmaceutical, biotech and medical device companies and government agencies have relied on PPD medical writers for more than 25 years to translate complex scientific information into high-quality, regulatory-compliant outputs across a comprehensive range of documents.
Pharmacovigilance
An unwavering dedication to excellence in patient safety is of the utmost importance, but it can be a challenge to keep pace with evolving regulations. Success requires proactive engagement with industry changes — and an approach that places quality and innovation first — whether your products are in development or on the market.
Project delivery
Partner with our experienced project managers, who have proven expertise across the full development continuum, to ensure your project runs smoothly. Project managers are closely aligned with your clinical operations to build trust, ensure clear accountability and tie our performance goals directly to our project team members.
Quality assurance
Ensuring the safety and integrity of clinical trials is critical for meeting ethical, regulatory and legal requirements that protect the rights and welfare of study participants. Our Quality Assurance (QA) solutions provide strategic and operational expertise, and our QA experts help you navigate the nuances of country-specific rules and regulations, mitigate risks, drive compliance and protect patients.
Regulatory affairs
Our strategic regulatory services span the full spectrum of activities and technical functions, so your project can be supported in regulatory development, licensing and life-cycle management, regulatory strategy input, and full-service regulatory partnerships. Regular deployment of process improvement techniques and use of the latest technology ensures quality of delivery.
Site contracts and payments
With growing pressure to accelerate therapeutic development, accelerating site contracting cycle times while ensuring site payments are accurate and on-time is critical. Our Site Contracts and Payments (SC&P) solutions help you get clinical trial sites activated and up and running sooner and deliver timely and precise payment processing and management so you become a sponsor of choice.
Site support
Study sites often struggle to recruit, train, and retain site staff, leaving them understaffed and overburdened. Our new Site Support Solutions help overcome site challenges to drive on-time study delivery and get new medications to patients faster. Our team works with you to create bespoke solutions and customized services that can be scaled to align with your needs as they evolve.
Study startup
Smooth site activations and accelerated start up cycle times are critical to meeting clinical trial timelines and grounding relationships with sites. Our Study Startup (SSU) solutions deliver the proven breadth and depth of expertise and apply tailored solutions needed to launch sites on-time.
Trusted FSP resources for drug development and post-marketing programs
Choosing the right FSP partner is critical to your drug development success. Nearly 400 companies have entrusted PPD FSP solutions to support critical components of their drug development and post-marketing programs. Your projects, goals and milestones become ours.
There’s a reason so many pharmaceutical companies trust in the quality of PPD FSP solutions. We’ve built our FSP expertise over many years, delivering a strong track record of reliable, high-quality services and support for clinical and marketed products, in addition to the convenience and ease of working with a single partner. PPD FSP solutions have capabilities in more than 160 countries, including our long-standing remote-based regional hubs in Central and Eastern Europe, China, India, Latin American and the Philippines. Our global footprint brings a nuanced understanding of local people, processes and regulatory landscapes, while enabling rapid onboarding across time zones.
We provide an extensive depth and breadth of talented, top-tier experts and unmatched therapeutic and functional expertise. Operational, functional, technical and therapeutic specialists — and laboratory services — are available for FSP engagements across all phases and therapeutic areas and at all levels, including senior roles. To ensure projects launch on time and stay on budget, our dedicated roles focus on rapidly ramping up engagements, keeping you informed with high-touch communications and applying on-demand staff and services as needed.
We recognize that an FSP partnership goes well beyond a mere staffing arrangement or a substitute for in-house resources. Our FSP engagements are an extension of and in alignment with our client’s culture and aspirations. We know that the most successful FSP relationships are forged when both partners value the collaborative aspects of the FSP model, fostering a sense of ownership and empowerment to maximize the value of the relationship. With our approach, our staff become more than just resources; they become an integral partner of the team, actively contributing their knowledge and insights, and bringing unique perspectives to the table to fully implement new and innovative strategies and help our clients meet their timelines.
In our 30+ years of providing FSP solutions, our proven track record ensures we will deliver the top-tier expertise you want and the reliable on-time delivery you need.
