Fortrea Completes Expansion of Clinical Pharmacology Solutions Following Targeted Investments at its Four Clinical Research Units in U.S. and U.K.
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.
To view this piece of content from ml.globenewswire.com, please give your consent at the top of this page.
About GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire by notified
Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire by notified
Alvotech Announces Positive Top-Line Results from a Pharmacokinetic Study for AVT05, a Proposed Biosimilar for Simponi® and Simponi Aria®29.11.2023 10:00:00 CET | Press release
The study, assessing pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi® (golimumab) in healthy adult subjects, met its primary endpoint Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive top-line results from a pharmacokinetic study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab). The study, which assessed the pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi in healthy adult subjects, met its primary endpoints. “These results demonstrate the strength of our platform approach to biosimilars development and manufacture, combining a well-designed and executed clinical study with the design of a high-quality manufacturing process and strong analytical capabilities,” said Joseph McClellan, Chief Scientific Officer. “As we progress more biosimilar candidates through clinical development and approval, w
The notes bought back by Municipality Finance will be removed from trading at Nasdaq Helsinki29.11.2023 10:00:00 CET | Press release
Municipality Finance Plc Stock exchange release 29 November 2023 at 11:00 am (EET) The notes bought back by Municipality Finance will be removed from trading at Nasdaq Helsinki On 27 November 2023 Municipality Finance Plc announced that it has bought back its EUR 10 million notes (ISIN XS2485560481) in whole. Nasdaq Helsinki has today approved MuniFin’s application to remove the notes from trading. MUNICIPALITY FINANCE PLC Further information: Joakim Holmström Executive Vice President, Capital Markets and Sustainability tel. +358 50 444 3638 MuniFin (Municipality Finance Plc) is one of Finland’s largest credit institutions. The owners of the company include Finnish municipalities, the public sector pension fund Keva and the Republic of Finland. MuniFin Group also includes the subsidiary company, Financial Advisory Services Inspira Ltd. The Group’s balance sheet totals approximately EUR 48 billion. MuniFin builds a better and more sustainable future with its customers. Our customers inc
Investeringsforeningen PortfolioManager - anmodning om suspension i afdeling29.11.2023 09:44:09 CET | pressemeddelelse
Pga. tekniske udfordringer har Investeringsforeningen PortfolioManager anmodet om suspension med handel af følgende afdelinger/andelsklasser: Afdelinger/andelsklasser i Investeringsforeningen PortfolioManagerFondskodeShortnameAI Alpha Lab Globale Aktier, kl nDK0062612644PMIAAN Suspensionen vil blive ophævet, når de tekniske udfordringer er løst, og det igen er muligt at stille priser. Eventuel henvendelse vedrørende denne meddelelse kan rettes til undertegnede på tlf. 38 42 21 42. Med venlig hilsen Nina Trolle Boldt, adm. direktør Fundmarket A/S
Buy-backs of shares in CoinShares International Limited29.11.2023 09:00:00 CET | Press release
29 November 2023 | SAINT HELIER, Jersey - As announced on 07 November 2023, the Board of Directors of CoinShares International Limited ("CoinShares" or the "Company") (Nasdaq Stockholm Market: CS; US OTCQX: CNSRF), Europe's leading alternative asset manager specialising in digital assets, resolved to extend a share buy-back program and repurchase shares on Nasdaq Stockholm Market during the period 07 November 2023, up to and including 30 May 2024 for total maximum amount of SEK 30 million in accordance with the authorisation from the Annual General Meeting on 31 May 2023. The Board of Directors’ resolution to implement the share buy-back program was made after the Board's review of the Company's capital structure and was implemented for the purposes of reducing the capital of the Company. The share buy-back program is carried out in accordance with the Market Abuse Regulation (EU) No 596/2014 ("MAR") and the Commission Delegated Regulation (EU) No 2016/1052 (the "Safe Harbour Regulatio
Deutsche Digital Assets Wins Pension Fund as Anchor Investor for DDA Crypto Select 10 ETP (SLCT)29.11.2023 09:00:00 CET | Press release
Institutional anchor investor for DDA Crypto Select 10 ETP (ISIN: DE000A3G3ZD0; WKN: A3G3ZD, Ticker: SLCT) The DDA Crypto Select 10 ETP reflects the MarketVector™ Digital Assets Max 10 VWAP Close Index (“MVDAMV”)With the ETP, investors are in a position to affordably gain exposure to a basket collection of (up to) the 10 most important crypto assetsThe ETP is 100% collateralized by coins held in an institutional custody solution FRANKFURT, Germany, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Deutsche Digital Assets GmbH has gained a renowned institutional anchor investor for the DDA Crypto Select 10 ETP (ISIN: DE000A3G3ZD0 | WKN: A3G3ZD), which was launched in June 2023. DDA prevailed against the competition in a selection process and was commissioned to design a crypto ETP that meets high quality standards and strict requirements of an institutional investor. After several months of preparation, this investment product can now be administered by a leading capital management company acting on be