20/08/2024 | Press release | Distributed by Public on 21/08/2024 17:22
August 20, 2024
When we help a sponsor not only complete enrollment, but complete it 30 days early, we consider it a win worth sharing.
Here's what happened: A global diagnostics company partnered with Fortrea on a pivotal trial to evaluate one of its assays. Although physicians use the assay on a broad patient population, enrollment had stalled and sites were frustrated.
A few challenges included:
Solving these problems required global coordination, aggressive patient recruitment and meticulous project management. Fortunately, Fortrea has the expertise and resources to solve complicated problems.
Here are a few strategies we used:
By thinking strategically and eliminating inefficiencies, Fortrea completed site selection and activation on time. Even better, we completed EU enrollment one month ahead of schedule.
By taking a partnership approach, Fortrea supported the sponsor with outsourcing and additional governance strategies. Fortrea also worked with the adjudication vendor and the sponsor to enhance data cleaning and adjudication, all while implementing plans to improve data entry and monitoring.
When the pivotal trial wraps up, the results will help the sponsor understand how its assay can improve outcomes in life-threatening situations. By enabling physicians to triage patients more quickly, and accurately, the assay has the potential to reduce hospital admissions without increasing adverse events.
As a diagnostics leader for over 30 years, Fortrea makes life-changing healthcare solutions possible. With insight-driven expertise, Fortrea works with diagnostics companies through all phases of development, from safety to postmarket support.
Our clinical validation services include:
The recruitment and enrollment challenges presented by the diagnostics pivotal trial were significant but within reach for Fortrea. With a global site network, sophisticated technology and a full roster of diagnostics development professionals, Fortrea makes the exceptional possible.
Are you ready to advance your diagnostics? Request a meeting today.
Prospective, noninterventional, single arm, longitudinal cohort multicenter study
NOTE: This study is still in progress as of 07/25/2024