Functional Service Partnerships to Support Clinical Trials and Marketed Products

FSP Solutions Deliver The Expertise 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 to navigate these changes while also predicting and managing the resources needed for projects to be successful.

That’s why more companies are turning to functional service providers for their outsourcing needs. FSP services help you advance your next drug development project — whether you need to fill small gaps in services or supplement 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 and in just the right amount.

Through expertise built over 25 years across more than 160 countries, PPD FSP solutions provide biotechnology and pharmaceutical organizations with functional support for clinical and marketed products. In every aspect of a drug development program — from site startup and monitoring to clinical data management to post-approval strategy — we act as a true partner to help solve your resource challenges.

Our FSP solutions provide access to customizable, reliable and cost-effective options to support key functional areas, fill gaps in internal capabilities or enhance functional expertise. And because we’re an experienced industry partner that sources professionals from the same talent pool as our full-service engagements, we position pharmaceutical companies for success.

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Top-tier Experts For Every FSP Services Project

When designing a project, you can’t always predict what talent you’ll need, let alone find that talent in an increasingly competitive market. Unlike other functional service providers, PPD FSP solutions enable biotech and pharmaceutical companies to solve their resource challenges by sourcing professionals from the same talent pool as our full-service engagements.

That means PPD FSP solutions provide the best of the best to each project — highly trained, top-tier experts who serve as extensions of your teams — and deliver more experience, knowledge and expertise than other functional service providers.

Singular Talent Pool

We employ the same best-in-class talent across all engagement models, ensuring every sponsor works with exceptionally trained professionals to successfully see their programs through.

As a result, all employees receive the full force of PPD’s global training, professional development and infrastructure. This training leads to consistently strong staff retention rates, which translates to continuity and long-term dedication to your project.

Flexible Solutions

It’s important to find flexible solutions to your resourcing challenges. FSP services are available across all functions, from clinical services to marketed products. Our services 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 services 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 to your projects.

Uniquely Dedicated To Your Success

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 and cost-effective options to support their evolving needs, and PPD FSP solutions deliver.
How we work for you:

  • It all starts with an implementation lead. This role is dedicated to driving seamless onboarding and establishes our professionals as an extension of your team.
  • From there, an operational delivery lead supports the duration of your FSP engagement. The operational delivery lead provides oversight, anticipating and responding to your needs with urgency and ensuring 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

Implementing an FSP partnership is complex.

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 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.

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 services. When using FSP services, 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, PPD 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 PPD 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

  • fixed price,
  • full-time equivalent (FTE),
  • unit-based,
  • output- or performance-based, and
  • time and materials.

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 25 years, delivering a strong track record of reliable, high-quality services with the convenience and ease of working with a single partner.

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. 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.

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 transfer success rates between 70% and 100% ,
  • eliminates risks involved in hiring and layoff cycles, and
  • condenses vendor contracts to reduce legal, financial and ongoing oversight burden.

FSP Solutions

By choosing an experienced, industry-leading functional service provider for one or multiple services, you gain flexibility and financial efficiencies, allowing you to focus on your areas of expertise.

Partnering with an FSP can guide you in solving product packaging, labeling and release process issues and efficiently navigating import and export regulations. Our global clinical supply team has demonstrated experience helping customers maximize efficiency and ensure on-site delivery of investigational products and all other study supplies, keeping your project on track.

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.

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.

For your project to succeed, you must verify the integrity of scientific data and ensure adherence to protocols, comply with international regulatory guidelines, and protect research subject rights and welfare. Our global quality and compliance services support you in these areas and more.

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.

Changes in technology have created the opportunity to digitally transform traditional study designs, ensure business continuity and advance life-saving clinical research around the world. We can support your decentralized and hybrid trials through

  • DCT regulatory insights,
  • direct-to and from-patient models,
  • electronic clinical outcomes assessments (eCOAs),
  • electronic patient-reported outcomes (ePROs) systems,
  • home health care,
  • patient wearables,
  • remote e-consent,
  • remote monitoring, and
  • telemedicine.

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.

Expert clinical research associates (CRAs) ensure the highest-quality review of data and effective interaction with study sites. You’ll work with our CRAs as they conduct on-site monitoring visits throughout the study to oversee data collection, ensure regulatory compliance and resolve data queries.

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.

We deploy the same top-tier talent across all engagements — from full-service to specific outsourced functions — so you get top-tier experts for each project. Regardless of the model, you’ll work with exceptionally trained and rigorously supported PPD staff to successfully set up and execute your programs.

Additional FSP Services And Resources From PPD

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