Fortrea Holdings Inc. (Fortrea) operates as a global contract research organization (‘CRO’). The company provides biopharmaceutical product and medical device development solutions to pharmaceutical, biotechnology and medical device customers.
The company provides phase I through IV clinical trial management, clinical pharmacology, and consulting services for its customers. The company has supported its global pharmaceutical, biotechnology, and medical device customers across more than 20 thera...
Fortrea Holdings Inc. (Fortrea) operates as a global contract research organization (‘CRO’). The company provides biopharmaceutical product and medical device development solutions to pharmaceutical, biotechnology and medical device customers.
The company provides phase I through IV clinical trial management, clinical pharmacology, and consulting services for its customers. The company has supported its global pharmaceutical, biotechnology, and medical device customers across more than 20 therapeutic areas, providing agile delivery models that include Full Service, Functional Service Provider (FSP), and Hybrid structures. The company provides services in about 100 countries. The company’s solutions streamline the biopharmaceutical product and medical device development process.
Fortrea combines decades of domain expertise with the nimbleness required to meet market demand for flexible engagements with large and small customers, delivering solutions that bring life-changing treatments to patients faster and creating value for all stakeholders. The company’s expertise in the biopharmaceutical product and medical device development process has enabled it to design service offerings to better meet the needs of customers. The company manages its business in one reporting segment — Clinical Services.
Business
Clinical Pharmacology: The company is a leader in clinical pharmacology, known for first-in-human and exploratory clinical pharmacology studies, as well as biopharma label support studies. The company offers an integrated clinical pharmacology solution that delivers precision, quality, and safety. The company's solutions include its clinical pharmacology units and external partnerships, project management, study design and monitoring, bioanalytics and biomarkers, pharmacokinetics (PK), modeling and simulation, and biometrics. Fortrea’s clinical research units (CRUs) are located in Leeds, U.K., offering 100 bed capacity; Dallas, Texas, with 100 bed capacity; Daytona, Florida, with 88 bed capacity; and Madison, Wisconsin, with 88 bed capacity. The company's offerings include deep expertise in areas such as radiolabeled absorption, metabolism, and excretion studies, as well as studies involving normal healthy volunteer and patient populations. All Fortrea CRUs have current good manufacturing practice (cGMP) pharmacies within them, enabling on-site manufacture of sterile and non-sterile drug products. A global bedside data capture system has been implemented across all CRUs.
Clinical Development: The company is a full-service provider of phase I through IV clinical and real-world evidence (RWE) studies, with a flexible approach to serving its customers. Clinical Development is Fortrea’s largest offering in terms of annual revenue contribution and has been for the last five years. Services include, but are not limited to, regulatory affairs, protocol design, operational planning, study and site start-up, patient recruitment, project management, comprehensive site and medical monitoring, data management and biostatistics, pharmacovigilance, medical writing, and mobile clinical services. The company's service offerings are supported by technological innovations, such as digital and decentralized clinical trial capabilities. The company focuses on rapidly expanding research areas such as oncology, central nervous system and neurodegenerative, metabolic disorders including MASH (metabolic dysfunction-associated steatohepatitis), immunology and inflammation (including autoimmune diseases and rheumatology), rare diseases, and cell and gene therapies. Additionally, the company has deep scientific expertise in a broad spectrum of therapeutic areas and diseases, such as cardiovascular disease, nephrology (renal), infectious diseases, dermatology, ophthalmology, respiratory, and women’s health, among others. Over the previous five years, the company has conducted more than 5,925 phase I through IV clinical trial projects involving more than 1,000,000 subjects. Clinical Development is enhanced by the company's pharmacology learnings, which it applies to future clinical programs. The company also has a medical device and diagnostics offering, which has conducted more than 500 studies in the previous five years.
The company offers its customers a tailored approach to clinical trial solutions through the use of three delivery models: Full Service, Functional Service Provider, and Hybrid.
Full Service: Integrates multiple disciplines from the company’s service offerings to comprehensively support its customers in their development programs across key geographies. The company’s service offering integrates protocol design and operational planning, site start-up and patient recruitment, project and program management, comprehensive site monitoring, centralized monitoring and medical data review, clinical and biometrics services, medical writing, and mobile clinical services. The company’s 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: Offers customers experienced personnel to perform targeted activities throughout their development programs. This approach reduces the company’s customers’ need to recruit and train dedicated internal resources which saves on cost and time and enables flexibility. The company’s service offering delivers comprehensive, strategic solutions designed to adapt to the level of customer control and infrastructure. The company’s 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: Provides the project-centric approach of a 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. The company’s ability to tailor its services to customer needs demonstrates the agility it can offer customers across the industry value chain. Fortrea offers this flexibility at a global scale and the company is positioned as a partner of choice for customers that require a tailored approach.
Consulting Services: The company provides comprehensive consulting services from product development and regulatory strategy to market access and health economics and outcomes research (HEOR), including RWE services. The company’s teams provide expertise, innovation and support for all product development stages (nonclinical and clinical phases I-IV), for small and large molecules, cell and gene therapies and biosimilars, across multiple therapeutic areas, including rare diseases to help customers define the most appropriate stakeholder strategy, evidence generation, and development pathway to optimize productivity, value and outcomes for life science innovation.
Strategy
The key elements of the company’s strategy are to lead with scientific and therapeutic expertise, expand in existing and novel therapeutic areas; support sites to solve the ‘last mile’ problems of patient recruitment and trial starts; pursue ‘Ideal Scale’ to support the research requirements of its customers; align with innovators through selective investment in technology, data and application of artificial intelligence (AI) for speed and simplification; become the partner of choice for pharmaceutical, biotechnology and medical device companies; create an inclusive culture for careers with meaning as a competitive advantage; and build on strengths in clinical pharmacology.
Service and Marketing
Fortrea’s global sales and operations teams provide dedicated customer support across pharmaceutical, biotechnology, and medical device customers, with active involvement from the company’s senior leaders. The company has a highly focused, experienced, and trained team of professional business development, account management, and support staff working on securing, servicing, and expanding business from both new and existing customers. This team leverages the relevant subject matter experts from across Fortrea to develop innovative solutions to the company’s customers’ needs.
The company aspires to provide world class customer relationship management through the collaboration of scientific, operational, and technical staff with its business development, customer facing project personnel, and senior leadership teams. From the first touchpoint with a potential customer, the company engages its therapeutic, scientific, and project personnel to build an understanding of the customer’s unique needs and culture. They remain embedded through the development of the opportunity and throughout the life of the project, program or partnership. This strategy allows the company to consult collaboratively with its customers throughout the lifecycle of its engagement.
As part of its ongoing commitment to customer service quality, Fortrea has instituted regular check-ins by senior leaders with customers in addition to its ongoing program of customer feedback surveys.
The company’s marketing efforts support the activities of its business development and customer facing staff. The company’s global marketing initiatives include integrated, digitally enabled, omni-channel campaigns and communication programs designed to help customers research its services, understand its differentiation, learn more about its capabilities and provide avenues to make it easier to engage with Fortrea. Beyond its customers, marketing initiatives engage a wide range of stakeholders including investigator sites, patients, healthy volunteers, and thought leaders. The company provides its perspective on current industry challenges and developments to create an ongoing dialogue with its current and prospective customers and collaborators and to promote its scientific expertise, differentiated service offerings, quality, and technology.
Government Regulation
The development, testing, manufacturing, labeling, storage, approval, promotion, marketing, distribution and post-approval monitoring and reporting of pharmaceutical, biological and medical device products are subject to rigorous regulation by numerous governmental authorities in the U.S. at the federal, state and local level, including the Food and Drug Administration (FDA), as well as those of other countries, such as the European Medicines Agency (EMA) in the European Union, the Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K., the National Medical Products Administration (NMPA) in China and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. These regulations apply to the company’s customers and are generally applicable to it when it is providing services to its customers, either as a result of their direct applicability, through a transfer of regulatory obligations from its customers, or as a consequence of acting as local legal representative on behalf of its customers in a particular country or countries.
In the U.S., the company may obtain health information that is subject to the privacy and security requirements of the Health Insurance Portability and Accountability Act (HIPAA) and other federal and state privacy and security laws, such as the California Consumer Privacy Act (CCPA) and the California Privacy Rights Act.
The company is also subject to privacy and security laws of other countries. For example, in the European Economic Area, the company is subject to the EU General Data Protection Regulation, and in the U.K., it is subject to the U.K. data protection regime consisting primarily of the U.K. General Data Protection Regulation and the U.K. Data Protection Act 2018 (together, the EU and U.K. data protection regulations are referred to as GDPR). In addition, similar data protection regulations addressing access, use, disclosure, and transfer of personal data have been enacted or updated in regions where the company does business, including in Asia, Latin America, and Europe.
The company is subject to various U.S. and non-U.S. anti-corruption laws, including the U.S. Foreign Corrupt Practices Act (FCPA) and the U.K. Bribery Act (the Bribery Act). Various worldwide anti-corruption laws, such as the FCPA and the Bribery Act prohibit the company and its officers, directors, employees and third parties acting on its behalf, including agents, from corruptly offering, promising, authorizing or providing anything of value to a foreign official for the purposes of influencing official decisions or obtaining or retaining business or otherwise obtaining favorable treatment.
The company’s global business operations also must be conducted in compliance with applicable export controls and economic sanctions laws and regulations, including those administered by the U.S. Treasury’s Office of Foreign Assets Control, the U.S. Department of State, the U.S. Department of Commerce, the United Nations Security Council, the European Union, His Majesty’s Treasury and other relevant sanctions authorities.
History
Fortrea Holdings Inc. was incorporated in 2023.