Highlighting Fortrea’s commitment to advancing rare disease clinical research

Over the last 5 years, our team at Fortrea has supported more than 820 rare disease studies, each with its own challenges and complexities. As part of our work creating the best path for drug development sponsors, we've created comprehensive, custom strategies that not only address the needs of patients and caregivers but also support sites and enable more efficient delivery.

To help sponsors better understand how we serve as an extension of their team to enhance and advance rare disease drug development programs, we're sharing three notable case studies. While these case studies represent only a fraction of our innovative work, we believe they demonstrate our ongoing commitment to creating trials that truly make a difference for those affected by rare diseases.

1. Successfully delivering an ultra-rare disease clinical trial in a competitive landscape

Fortrea's Diseases, Advanced Therapies and Pediatrics Team (RAPT) was selected to deliver a Phase III study for patients living with the ultra-rare disease limb-girdle muscular dystrophy type 2I (LGMD2I). Another sponsor was simultaneously recruiting LGMD2I patients, increasing the demand for a limited pool of qualified patients and experienced sites in an already difficult-to-recruit space.

We share how the team worked to find appropriate sites, develop patient materials and evaluate patient-centric practices to exceed the sponsor’s recruitment goals and deliver timely data for interim review.

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2. Collaborative practices advance a rare ophthalmological disease clinical trial

Fortrea forged strong connections with sites and an advocacy group to create a high level of participant interest in a rare disease clinical trial. Learn how the team applied its ophthalmological, rare disease and operational expertise to ultimately surpass recruitment targets by more than ~20% of the sponsor's original target-and help the sponsor achieve an orphan drug designation for their treatment.

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3. Innovative digital approaches help recruit and retain patients in a rare disease hematology study

Tasked with supporting a five-year multi-national rare disease study and more than 10 clinical outcome assessments (COAs), Fortrea designed a decentralized approach and incorporated digital health technology to reduce the patient burden and protect study endpoints.

Learn how Fortrea applied its expertise to navigate challenges, ensure compliance with regulatory standards and enable high-quality data collection to successfully deliver this complex, rare disease study.

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Get more details on how Fortrea can enhance your rare disease trial: https://www.fortrea.com/therapeutics/rare-diseases