FSP Delivery Models in Clinical Trials
The one-size-fits-all outsourcing model doesn't work for today's sponsors. That’s why we innovate and adapt to your evolving drug development needs – both now and in the future.
Our FSP delivery models are designed for high performance on day one and power ongoing, trusted relationships
Our highly skilled talent, flexible resources, and guidance from our industry-leading outsourcing experts will provide you with the resilient clinical development strategies and customized models needed for success.
Access the talent you need
We offer proactive and customized recruitment solutions, engaging best-fit talent worldwide. Our strategic placement of the right people drives success, enhances productivity, and creates efficiencies. Our dedicated talent acquisition team collaborates with Parexel's recruitment engine for maximum impact. We provide customized training programs, prioritizing skill enhancement. We offer flexibility in transitioning between delivery models to optimize speed and cost, adapting to the evolving drug development landscape.
To accelerate your drug development around the world, Parexel is continuously strengthening infrastructure to access investigator sites in new locations and emerging markets. Our talent hubs located in the Americas, Europe, the Middle East, Africa, and APAC provide you with diverse experts around the globe. Whether you need us in one country or 100, our global network of premium facilities and local professionals are all connected in real time.
Our industry is going through a significant transformation right now, whether that's macroeconomic industry trends, market pressures, or truthfully, the transformation in technology that we're seeing right now. And we're ready to step through each of those with our clients to design the right model and the right infrastructure to support from an FSP perspective.
A one size fits all model is no longer the right approach. It's not either full service or FSP, it's where is the right combination to engage each of those models. And that's unique for every customer. One of the things that we do is we help our customers sit down and analyze the model and what's best for them in what particular situations in the right time, in the right place. And Parexel is uniquely able to do that based on our global structure where we have an umbrella of global clinical and data operations where our full service and our FSP units sit side by side, which enhances collaboration as needed with the necessary firewalls in place, of course, to protect confidentiality. And we're able to really have a more flexible and agile resourcing model for our clients to get the right people in the right locations in the right time.
So I think one of our key differentiators is our people-centric approach. We do everything with heart. That includes our people and finding the right people in the right locations at the right time, and also considering our client's culture and what's the right fit for them. We have a dedicated talent acquisition department that works ahead of the curve to identify the right talent in the right locations for us all and to make sure that we have the resources available and in place for our clients. The other key thing that we do is we grow that talent throughout their career so that they can grow along with our sponsors in their model and really have that continuum of their career as well.
We love to work with our clients throughout their entire development journey to really create a true partnership that has to be founded in trust and also collaboration. We want to sit with our clients early in their process to really develop the right approach for their outsourcing, going through the transition together, planning and all the way through to execution so that we can really deliver on what they need in their FSP models.
Advantages
Sponsor-centric delivery models
As your partner, we’ll develop a unique model that meets and evolves with your goals, drawing upon our deep experience in strategic partnerships. By aligning goals, processes, culture, and a sense of urgency, we work together with your team to define key roles and responsibilities, prepare a global staffing footprint, and delivery plan. While you retain control of your development strategy, we implement and stay accountable through execution.
Performance powered by people
We’ll drive and propel your success through the strength of our mobile, global, analytical workforces, assigning them where their capabilities are best applied and dedicating the highest caliber talent, with performance oversight and access to continuous system and process innovation.
To evolve and retain talent, we leverage industry-leading training and advocate for career ladders, providing employees with a plan for long-term progress in their professional lives.
Empowering change with agility
Our solutions are built to help you address today’s evolving clinical development landscape and innovate for the future. Embracing the dynamic nature of the industry, agility is a cornerstone of our services. Our experts drive change at an operational level and cultural level, enabling quick adoption of rapidly advancing technologies. To accelerate development, we find skilled resources in your target countries.
Patient-focused innovation
To help you develop effective, patient-focused therapies that deliver meaningful benefits, we help you adapt and scale where you need it, beginning early in development and including patient insights at every step. Led by passionate people with technical expertise, we share your commitment to accelerate delivery of life-changing medicines to patients.
Functional services offered
Clinical operations
From study start-up to quality assurance and risk management, our clinical operations personnel (CRAs, study managers, start-up specialists, operations managers, and data managers) provide flexible and customized solutions to meet your specific needs while ensuring high-quality clinical trial execution.
You'll benefit from flexible resource allocation, improved cost-efficiency, enhanced quality, and accelerated timelines. We deliver tailored solutions that are aligned with your unique needs.
Our clinical operations personnel can complement your internal expertise or handle all operational aspects of your studies.
Data management
Our data operations experts efficiently and accurately manage clinical trial data throughout its lifecycle. This includes data collection, processing, validation, analysis, and reporting. The team ensures that data is captured in a standardized and reliable manner, adhering to regulatory requirements and industry best practices.
The data operations team collaborates closely with sponsors, clinical operations teams, and other stakeholders to develop data management plans, establish data standards, and implement data capture strategies. They are responsible for setting up electronic data capture systems, developing data validation checks, and cleaning the data to ensure its quality and integrity.
Medical affairs
Our medical affairs professionals (medical science liaisons, clinical trial liaisons, and clinical nurse educators) work closely with you to establish and implement strategic plans for your products. This involves providing scientific and medical expertise, evidence generation, and strategic guidance to drive product development, support regulatory submissions, and facilitate patient access.
Additionally, they actively engage with key opinion leaders, healthcare professionals, regulatory authorities, and patient advocacy groups to foster relationships and garner valuable insights.
Medical writing
Our medical writing team works closely with you to create high-quality, well-structured, and scientifically accurate documents that support your clinical development and regulatory strategies.
Our team includes roles such as associate medical writers, senior medical writers, document quality reviewer, principal document quality reviewer, document specialist, lead document specialist, and medical writing support coordinator.
This collective team handles everything from document writing and preparation for product development, approval, and commercialization to authoring, medical writing project management, trial disclosure, and publishing.
Regulatory
Our global regulatory colleagues (including regulatory affairs managers, compliance experts and project managers) provide expertise across a range of outsourced regulatory solutions, including regulatory dossier compilation, publishing and dispatch, clinical trial applications, centralized CMC and labelling and post-approval submissions and lifecycle management. We also partner with clients on project-based deliverables including regulatory strategy, market authorization submissions, M&A license transfers and RIM – data entry, data cleansing, data migration.
We work with clients on asset-based outsourcing, often for mature products or low-risk portfolios or on a functional basis for activities like CMC, labeling or publishing. Services are delivered by a unitized (deliverable) model, or an FSP (dedicated FTE) model.
By outsourcing and consolidating non-core regulatory activities, our experts can ensure your regulatory team focuses on core business activities and your development pipeline.
Pharmacovigilance
Our pharmacovigilance function serves to ensure the safety and well-being of patients participating in clinical trials. Our PV team is responsible for the efficient collection, evaluation, and reporting of adverse events and other safety-related information to the relevant regulatory authorities. We comply with global regulatory guidelines and industry standards to ensure the highest level of patient protection.
Through close collaboration with our FSP partners, we establish and maintain robust safety management plans, develop standard operating procedures, and conduct thorough safety trainings.
Translational medicine
Our translational medicine group -- comprised of scientific directors, biomarker sample management specialists, biomarker sample operations associates, and precision medicine associate directors -- conceives and implements data-driven, target therapy development strategies to deliver novel therapies that treat patients based on their unique genomic and biomarker characteristics. Our genomic medicine scientists apply expertise, innovation and state-of-the-art methodologies in the strategic and operational implementation of genomics and biomarker services to help clients:
- Better understand the genetic/genomic basis for the disease, drug, target, and pathway
- Differentiate drugs from competitor medicines in development or on the market
- Stratify drug responders/non-responders and enrich clinical trial design
- Develop biomarker and companion diagnostics strategies
- Inform the benefit-risk profile of personalized medicine
Our experts in delivery
Deb Tatton
President, Global Clinical & Data Operations
Jenny Denney
Executive Vice President and Global Head of FSP
Neil Berger
Vice President, FSP Commercial & Operational Strategy
Kerri McCaul-Claus
Vice President, Head of FSP Biometrics
Michelle Verhaeghe
Vice President, Head of FSP Clinical Operations
Conal Burgess
President and Global Head, Enterprise Partnerships
Katie Connelly
Senior Vice President, Global Head of Regulatory Affairs
Angela Qu, M.D., Ph.D.
Senior Vice President, Translational Medicine, Global Head of Biomarkers & Genomic Medicine
Our experts in delivery
Deb Tatton
President, Global Clinical & Data Operations
Jenny Denney
Executive Vice President and Global Head of FSP
Neil Berger
Vice President, FSP Commercial & Operational Strategy
Kerri McCaul-Claus
Vice President, Head of FSP Biometrics
Michelle Verhaeghe
Vice President, Head of FSP Clinical Operations
Accelerate your success: Solutions at the forefront of the industry
At Parexel, our FSP delivery models allow us to rapidly deploy experienced, geographically diverse resources to meet client needs. Our talent acquisition process is highly efficient, with recruiters aligned to sponsors for better understanding of their requirements.
Parexel's FSP partnerships particularly excel in deploying site relationship partners, focusing on strengthening site engagement and prioritizing investigator and patient needs. This patient-centric approach is a source of pride for Parexel, as it embeds talent dedicated to advocating for patients throughout the complex clinical development process.
When I go in, I go all in and I'm passionate about what I do. I feel like at the end of the day, what I am doing is impacting somebody.
My name's Hena Sleem and I am an executive director of Clinical Operations at Parexel.
FSP stands for functional service provider. So as an FSP provider, we're able to quickly deploy resources with required expertise, experience, geographic diversity, going into regions where we have incredible pools of talent, access to the best patient populations as well.
Parexel's time to fill metric is best in class. Our talent acquisition teams are already hiring in key locations for key roles before there's actually open positions, and are recruiters from our talent acquisition team are geographically aligned to sponsors so that way they understand the sponsor's cultures, the needs that the client has in order to be able to be successful in the role.
An area that FSP often supports right now is the deployment of site relationship partners. This allows sponsors to further strengthen the engagement with sites. The core tenet behind this role is to focus on the investigator patient's needs and shifting them to the center of the clinical trial. At Parexel, we're very proud that our FSP partnerships are delivering with heart by embedding talent who have the primary focus of advocating and connecting the patient voice into the broader and complex clinical development journey.
Case Study
Strategic FSP model transformation
Situation
Solution
Outcome
A top five biopharmaceutical company set a goal for transitioning from a predominantly full-service outsourcing (FSO) to a functional service provider (FSP) model, requiring an extensive reorganization of its global clinical operations. The transformation aimed to create resource efficiencies, increase agility, and optimize clinical operations across a global portfolio of more than 75 studies spanning four continents, 41 countries.
- The reorganization within the sponsor’s global clinical operations program and the transition from a predominantly FSO to an FSP model marks a significant transformation milestone, with a goal of recruiting 580+ roles by December 2024 (with recruitment beginning in October 2023).
- Implementation of a strategic FSP model required redefining traditional roles, innovating tasks and responsibilities, and talent redeployment in support of the shifting pipeline priorities. Moving away from other incumbent vendors, they partnered with Parexel and one other vendor to implement the new model with an equal distribution of requisitions assigned to both.
Situation
A top five biopharmaceutical company set a goal for transitioning from a predominantly full-service outsourcing (FSO) to a functional service provider (FSP) model, requiring an extensive reorganization of its global clinical operations. The transformation aimed to create resource efficiencies, increase agility, and optimize clinical operations across a global portfolio of more than 75 studies spanning four continents, 41 countries.
- The reorganization within the sponsor’s global clinical operations program and the transition from a predominantly FSO to an FSP model marks a significant transformation milestone, with a goal of recruiting 580+ roles by December 2024 (with recruitment beginning in October 2023).
- Implementation of a strategic FSP model required redefining traditional roles, innovating tasks and responsibilities, and talent redeployment in support of the shifting pipeline priorities. Moving away from other incumbent vendors, they partnered with Parexel and one other vendor to implement the new model with an equal distribution of requisitions assigned to both.
Solution
Outcome
FAQs
FSP stands for Functional Service Provider in clinical research. It is a model in which a company outsources specific functional activities or services to a third-party service provider. FSPs work closely with the sponsor organization to provide specialized expertise, resources, and operational support in areas such as data management, biostatistics, clinical monitoring, drug safety, and regulatory affairs. By engaging an FSP, sponsors can enhance efficiency, flexibility, and cost-effectiveness in delivering clinical trials.
FSO stands for Functional Service Outsourcing, while FSP stands for Functional Service Provider. Both FSO and FSP are models commonly used in the pharmaceutical and clinical research industry to support specific functions or services required in a clinical trial.
FSO refers to the outsourcing of specific functions or activities to an external service provider. In an FSO model, the service provider takes ownership of the entire function and provides all the necessary resources, infrastructure, and expertise to perform the activities. For example, a company may outsource its clinical data management function to an FSO provider.
On the other hand, FSP refers to the engagement of an external service provider to provide specific expertise or resources while working in collaboration with the internal team. In an FSP model, the service provider works as an extension of the internal team, focusing on providing the required expertise or resources for a specific function. For example, a company may engage an FSP provider to provide biostatistics support for a particular clinical trial.
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