Adds speed and agility with cGMP production at on-site pharmacies, adds capacity, improves flexible therapeutic capabilities and enhances experience for study volunteers
DURHAM, N.C., Nov. 02, 2023 (GLOBE NEWSWIRE) — Fortrea (Nasdaq: FTRE) (the “Company”), a leading global contract research organization (CRO), today announced that it has completed a multi-year effort to expand its clinical pharmacology solutions and capacity, which are now fully available for customers. The expansion includes a 100,000 square feet state-of-the-art facility in Leeds, U.K. as well as approximately 20,000 square feet of new or renovated space, adding capacity and capabilities across its clinical research units (CRUs) in Dallas, Texas; Daytona, Florida; and Madison, Wisconsin.
“The increasing complexity of clinical pharmacology studies demands fit-for-purpose infrastructure, experience and expertise to protect the safety of study participants and the integrity of critically important data,” said Oren Cohen, M.D., Fortrea’s president of Clinical Pharmacology and chief medical officer. “Our integrated platform of services includes best-in-class infrastructure and experienced professionals who are fully dedicated to clinical pharmacology, including physicians, nurses, clinical scientists, CRAs and pharmacokineticists. The investments we have made target the capabilities and capacity that customers need to accurately assess early pipeline candidates and speed those with promise to later-phase development and ultimately to patients who need them.”
Facility enhancements following the completed expansion include Fortrea’s new CRU in Leeds as well as purpose-built rooms in Madison and Daytona designed for flexibility in executing complex early phase clinical studies. Improvements in recreational, living and “work-from-home” spaces at Fortrea CRUs have been constructed to enhance the experience of volunteers participating in research at the sites.
The expansion of Fortrea’s early clinical development pharmacy services facilities includes new state-of-the-art cGMP pharmacies in the Leeds and Daytona CRUs. All Fortrea CRUs will now have cGMP pharmacies within them. This enables on-site manufacture of sterile and non-sterile drug product. The design of its GMP-compliant facilities provides safe handling and delivery of GMP-quality drug product for the unique demands of clinical pharmacology studies, focusing on efficiency and flexibility with the level of controls expected by regulatory authorities and sponsors.
Enhancements in science and technology include the addition of artificial intelligence-enabled programs that optimize bed space utilization and clinic scheduling, and the application of failure modes and effects analysis to de-risk study execution before a study begins. Following investments in data collection systems, all clinical pharmacology study data collected within Fortrea’s CRUs are input directly into a digital bedside data capture system, which can also be used as an efficient electronic data capture solution.
“I believe Fortrea’s early clinical development solutions set a new standard for what the research industry should expect from its partners,” said Dr. Cohen. “I’m so proud of this team and know they will also benefit from the changes we have made. Just as they are inspired by our mission of bringing life-changing treatments to patients faster, I’m inspired by their dedication each day as we deliver solutions to our customers.”
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology enabled trial solutions and post-approval services.
Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team of more than 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally.
Cautionary Statement Regarding Forward-Looking Statements
Some of the statements in this press release, particularly those relating to the anticipated financial and other benefits, including, but not limited to, whether the investments at clinical research units in U.S. and U.K. will add capacity, improve therapeutic capabilities, enhance experience for study volunteers, speed development to later-phase trials and improve the integrity of data and whether the addition of artificial intelligence-enabled programs will optimize bed space utilization and clinic scheduling, are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements involve risks and uncertainties, many of which are beyond the Company’s control. Actual results could differ materially from expectations expressed or implied in the forward-looking statements if one or more of the underlying assumptions or expectations prove to be inaccurate or are unrealized. Important factors that could cause actual results to differ materially from such expectations are and will be detailed in Fortrea’s registration statement on Form 10 initially filed with the SEC on May 15, 2023 (as amended and further supplemented), Fortrea’s quarterly report on Form 10-Q filed with the SEC on August 14, 2023, and in Fortrea’s other filings with the SEC. These forward-looking statements are based on management’s current expectations and are subject to certain risks, uncertainty and changes in circumstances. Fortrea does not undertake responsibility for updating these statements, and these statement speak only as of the date of this press release.
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