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. As a result, it’s critical for drug developers to engage a partner that can navigate these changes and predict and manage the resources 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 functions. FSP models also increase flexibility and provide access to the exact expertise your project needs, when you need it, in just the right amount.
With over 25 years of experience across more than 160 countries, our FSP solutions help biotech and biopharmaceutical companies meet their timelines by delivering the best of the best: hard-to-find, top-tier staff who bring a customer-first, problem-solving mindset to the clinical development services we provide.
Explore the growth and utilization of FSP partnerships, the future of these models, and the keys to successfully leverage them
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 more experience, knowledge and a wider breadth of expertise than other functional service providers, uniquely positioning us to provide the right experience and knowledge to fill immediate 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. We act as a true partner to help solve your resource challenges and provide support for clinical and marketed products across every aspect of a drug development program — from site startup and monitoring to clinical data management to post-approval strategy. We position biotech and pharmaceutical companies for success.
expert research professionals
years of FSP experience
customers use our FSP support 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 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
Problem-solving professionals provide the right expertise
To attract the best of the best, we have a dedicated FSP recruitment team of over 130 professionals. Attracting top-tier talent is about creating an excellent culture and maintaining our commitment to upskilling and reskilling our employees, expanding skill sets, and training for future needs.
To keep employees on top of ever-evolving regulations and technology changes, we offer award-winning professional development programs, as demonstrated by our ranking as a leading business for employee learning and development for 11 consecutive years in Training magazine’s Top 100 list. Our industry-leading retention, in turn, delivers business continuity and the confidence of knowing that your programs are supported by quality professionals who apply the right experience, knowledge and expertise.
Developing a team of reliable experts in hyper-competitive talent marketplaces also demands innovative training approaches. 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. In addition, functional and therapeutic area tools (like our comprehensive cell and gene therapy training and forums), resources, and role-specific trainings (including our CRA Academy) support employees throughout the entire project lifecycle – from startup to maintenance to closeout – to provide ongoing guidance and support.
Our professional development and learning culture help make us a great company to work for, leading to increased employee engagement and retention. We are a passionate group of can-do problem solvers, offering consistent staffing and low turnover to provide much-needed resource reliability and continuity, which translates to continuity and long-term dedication to your project.
Flexible, personalized solutions
It’s important to find the right solutions to your resourcing challenges. PPD™ FSP solutions offer customized engagements tailored to your exact needs and requirements. 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 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.
How our dedicated roles work for you:
- Implementation lead (IL): It starts with this role, dedicated to driving seamless onboarding 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.
Read the Contract Pharma article expanding on the significant role of implementation leads for research projects Learn more about how implementation leads keep our FSP projects a step ahead
Operations delivery lead
To establish, maintain and nurture the partnership 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 oversight, planning and partnership-building that creates greater stability, 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. Pharmaceutical companies employ a variety of models to meet that need, including FSP solutions. When using our solutions, models include:
- the outsourcing of one or multiple functions, such as data management or monitoring,
- a hybrid between FSP services and full-service outsourcing (FSO), and
- customized FSP models.
Regardless of whether we support one or more functions through an FSP-only or hybrid 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.
No matter the scope of your project, our FSP teams deliver easy onboarding and continuous collaboration that establishes trust and accountability.
Flexible engagements to achieve project goals
The flexibility of using different engagement models — or a blend of those services — means you can always choose what is right for you. An engagement with our FSP solutions is always customized to your requirements.
We partner with you to offer the best FSP model for your project needs, including a flexible mix of systems, processes, oversight and facilities — yours or ours. Our customers benefit from innovative pricing models that accommodate various contract structures from the following:
- fixed price
- full-time equivalent (FTE)
- unit-based
- output- or performance-based
- time and materials
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 300 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, and 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.
In our 25+ 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.
