Fortrea offers customers a tailored approach to clinical trial solutions through the use of three delivery models: Full Service, Functional Service Provider (FSP) and Hybrid. We offer this flexibility at a global scale and as we strive to be your partner of choice for tailored CRO services.
DEDICATED OUTSOURCING SUPPORT AT ANY POINT IN YOUR CLINICAL TRIAL JOURNEY
Full, Functional & Hybrid Service Models
How Being a Consultative Partner Can Make a Difference
Fortrea provides customized clinical trial delivery solutions to sponsors around the world, using a consultative approach to respond to their individual needs and priorities. We consult with sponsors and apply our decades of clinical development experience to help you craft the right delivery model for your needs. Let Fortrea be the difference in your clinical trial.
Structure and Agility – Keys to Flexible Delivery Models
Fortrea applies the right delivery model for each customer through a unified delivery structure and inherent agility that drives flexibility for clients. Let Fortrea’s agility open the way to employing a flexible delivery model that fits your needs – today and into the future.
Connecting Talent and Innovation to Agile Clinical Development
Enabled by our distinct unified delivery structure, Fortrea brings the right people at the right time to meet sponsor needs in executing agile clinical trials. Fortrea connects talent and innovation to deliver clinical development with agility.
Delivering Patient-Centered Clinical Trials
Fortrea proactively problem-solves using scientific, therapeutic area and technological expertise combined with a deep patient understanding. Fortrea partners with sponsors to create and deliver patient-centric clinical trials.
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How Being a Consultative Partner Can Make a Difference
Structure and Agility – Keys to Flexible Delivery Models
Connecting Talent and Innovation to Agile Clinical Development
Delivering Patient-Centered Clinical Trials
Full Service
Combines multiple disciplines to comprehensively support you in development programs across key geographies. Our service offering integrates protocol design and operational planning, site start-up and patient recruitment, project and program management, comprehensive site monitoring, clinical and biometrics services, medical writing, and mobile clinical services. Our project-centric approach utilizes dynamic team resourcing with agile role-based structures. This approach allows for more adaptability to trial types with customer-tailored designs.
Functional Service Provider
Whether you need to extend your clinical data teams or clinical operations staff, we offer one of the world’s largest dedicated CRO functional service provider groups in the industry. Count on a team of more than 7,000 experienced professionals across more than 60 countries to help advance your mission through outsourced assignments – saving time and costs and enhancing flexibility. Our service offering delivers comprehensive, strategic solutions designed to adapt to the level of customer control and infrastructure. Our FSP team can provide dedicated offerings in clinical operations, clinical data management, biostatistics, statistical programming, pharmacovigilance, mobile clinical services, and medical writing, among other customized solutions.
Hybrid
Leverage the project-centric approach of our full-service model while integrating FSP models, to varying degrees on large portfolios with therapeutic similarities, to drive efficiencies and enhance sponsor control for clinical development. Our ability to tailor our services to your needs demonstrates the flexibility we offer customers worldwide.
Whether you need to advance local, regional or global trials, rely on our specialists’ focused backgrounds—spanning medicine and biological sciences—to help you make strategic decisions that can lead to better outcomes.
FSP Clinical Data Solutions
We believe in harnessing technology for human good. We help deliver quicker insights from data acquisition through to analytics, so you can focus on advancing life-changing therapies.
Data Management
Move your program forward by partnering with experts from our clinical data solutions team of nearly 1600 clinical data managers. Our tenured professionals know how to advance your data-driven solutions, drawing on their 15-year average industry experience and more than 10 years supporting sponsors through the Fortrea FSP platform.
Our FSP data management group can apply their insights across all major therapeutic areas and deliver expertise in:
- Electronic case report forms (eCRF) development
- Database builds
- Data entry, query management, review, coding and SAE reconciliation
- Timely database lock and final transfer
Innovative data management helps to ensure integrity, quality and accountability in your process. We offer system-agnostic support and draw on our experience supporting electronic data capture (EDC) systems since 1997 from the industry’s best platforms.
Biostatistics & Programming
Get appropriate interpretation of your study results and create efficiencies across your portfolio with our team of more than 700 SAS® programmers and biostatisticians. Averaging 10 years of drug, device or biologics development expertise, our team knows how to deliver customized, quality statistical services across every aspect of clinical development. Trust in our 30 years of experience to advance your harmonized SAS environment and provide 24/7 continuity across a global infrastructure.
Our comprehensive biometric solutions also include our FSP statistical analysis and research center (SARC), which works across your projects to provide guidance in clinical trial design, simulations, statistical methodology–as well as support your data safety monitoring board (DSMB).
Standards
Enhance your operational effectiveness with our proven success in SAS® dataset conversions and integration. Our biostatistics programming team has converted many datasets for legacy studies, Integrated Summary of Safety / Integrated Summary of Efficacy (ISS/ISEs) and warehousing purposes. We have harmonized databases both on ISS and ISE levels, as well as conversions to internal customer-defined legacy system specifications. Our clients also benefit from customized Study Data Tabulation Model (SDTM) training creation, implementation guides and consultancy services.
As a CDISC Registered Solutions Provider and Platinum member, our clinical data solutions team at Fortrea FSP knows how to generate compliant deliverables. Since 2004, we have helped clients implement CDISC standards. Our integrated services include consulting, data conversions and data warehousing—with or without analytics.
In addition, Fortrea is a three-time recipient of the Outstanding Performer award from CDISC for our contributions toward the ADaM standards.
eClinical
Our strength lies in platform agnosticism and our analytics capabilities enable us to apply leading-edge technology that can deliver:
- A strong design and programmatic interface—including features to support team development and allow reuse of common components
- An IT infrastructure and server environment that provides enterprise-level deployment options such as security, access control and user management, and high-performance data processing.
Working with more than 20 EDC vendors, our FSP team at Fortrea leverages our EDC system knowledge transfer agreements with Mednet (iMednet), Merge (eCOS), Medidata (Rave) and Oracle (InForm). We work alongside your team to partner with an optimal EDC vendor, one that can provide industry-leading technological expertise, a high level of customer support and a cost-effective, user-friendly data collection system.
As an industry leader in clinical data technology, our FSP team also strategically integrates independent analytics tools, such as BOXI, JReview, SAS®, Cognos and Spotfire. Wielding these tools and rendering data in this capacity is an art form requiring well-established visual analytics principles, theories and a talented pool of programming individuals well-versed in the following platforms:
- Spotfire®
- Xcellerate®
- ARGUS Cloud
- SaaS Solutions
FSP Clinical Operations
Supplement your clinical operations program with an experienced partner at your side. As a clinical service provider, our team at Fortrea has been engaged in global, scalable FSP relationships with biopharmaceutical clients for more than 30 years across more than 60 countries. We know how to serve as a vital extension of your resources across a number of functions—including clinical monitoring, drug safety, regulatory and clinical trial management—all aligned to your culture, mission and business goals.
Our engagements are customized to your needs—from a few dedicated full-time equivalent (FTE) staff to hundreds of FTEs across several functional areas. Project-managed by you, employed by Fortrea, we provide the specialized staff you need for the following job functions:
- Clinical Research Associates (CRAs)
- Project Managers
- Program Leaders
- Data Managers
- Data Coordinators and Programmers
- Medical Writers
- Regulatory Staff
- Biostatisticians
- Clinical Trial Leads (CTLs)
- Clinical Trial Managers (CTMs)
With our resource menu at your disposal, you can quickly ramp up or down your staffing levels—without focusing on recruitment and retention—and optimize your cost distribution. We continually invest in attracting and retaining the right talent, working with people who can integrate into your teams and deliver seamless business continuity.
Our team is here to help deliver confidence to your team. By starting with consistent delivery of flexible resources and functional services, we believe in being more than a partner. In fact, we often foster long-term, productive relationships that last more than 10 years. Our focus is centered on your needs as we continue to invest in building, training and retaining our workforce on your behalf, with a focus on innovation, flexibility and cost competitiveness.
Tailor our FSP delivery model to your unique requirements.
FSP Model
You retain overall accountability, responsibility and direction of the study— including provision of direct management and work assignments to your assigned resources.
Enhanced FTE: Input-based model
You retain overall accountability, responsibility and direction of the study, while our team at Fortrea is responsible for liaising with you and making work assignments directly with your assigned resources.
Unit Deliverable: Output-based model
We manage the day-to-day tasks and the resources assigned to your program. We retain responsibility for decisions concerned with hiring and line management of our employees who will work from Fortrea offices or who are field-based. The staff members assigned can use our tools and systems or yours.
Throughout every interaction, we implement rigorous and visible Key Performance Indicators (KPIs) as core components of our quality control metrics to enable the transparency and accountability you need to move forward.
We are here to manage your clinical operations and clinical trials with greater efficiency and flexibility. By linking quality people, intelligent process and deep technical expertise, we can deliver performance measurement and accountability, so you can focus on developing innovative therapies for patients.
Your needs. Our solutions.
As a provider of comprehensive Phase I through IV clinical trial management, clinical pharmacology, patient access solutions and other enabling services, Fortrea partners with emerging and large biopharma and medical device and diagnostic companies to drive healthcare innovation throughout the world.
