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.
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.
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.
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).
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.
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:
- 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
- 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.