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 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.
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 specialsts, 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 market 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 PV 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