How Fortrea helped enroll over 5,000 patients 30 days early
When we help a sponsor not only complete enrollment, but complete it 30 days early, we consider it a win worth sharing.
Creating a combined advanced therapy medicinal product as an SME in the EU
Combined advanced therapy medicinal products (CATMPs) have a specific product classification under the European Medicines Agency (EMA).
Dr. Gillespie goes to Capitol Hill to advocate for rare kidney disease
Dr. Barbara Gillespie, Vice President & Therapeutic Strategy Leader at Fortrea, recently participated in “Rare Kidneys on the Hill Day” on July 25th, joining patients, caregivers, physicians and researchers on Capitol Hill to speak with members of Congress and raise awareness about rare kidney disease (RKD).
The journey of Advanced Therapy Medicinal Product (ATMP) studies in the European Union
Sponsors developing combined advanced therapy medicinal products (CATMPs) play an important role in advancing potentially groundbreaking opportunities and addressing unmet healthcare needs.
Clinical Development in the Precision Medicine Era
The era of precision medicine is reshaping oncology trials, offering unprecedented opportunities to tailor treatments to individual genetic profiles. This transformation brings challenges in trial design and execution, and companies must adapt their clinical development strategies to stay ahead.
Diversity Action Plans: What sponsors need to know about the latest FDA guidance
The FDA’s much-anticipated Diversity Action Plan guidance was published on June 26th, 2024. This is still a draft guidance with a comment period of 90 days; Fortrea’s Diversity Workstream group will be working with Fortrea’s Regulatory Intelligence team to compile comments and submit them to the FDA.
Importance of patient perspectives in neurology clinical trials
Incorporating patient perspectives through interviews in neurology clinical trials
It is never too early to start a strategic plan for oncology product development in the APAC region
In oncology, a goal-oriented, holistic strategic plan is crucial, even in the earliest phases of product development.
Empowering young voices in pediatric clinical trials: Fortrea’s commitment to child rights and participation
Learn about the experiences of the young participants involved in the clinical trials.