CASE STUDY Multi-read blinded review rescue study
This case study highlights a global Phase 3 clinical trial in the therapeutic area of endometrial health. Sponsored by a leading pharmaceutical company, the study involved 5,200 subjects and generated 10,400 independent reads, spanning multiple regions worldwide.
The Pathology Services group of Eurofins Central Laboratory brought extensive experience in global clinical trial support, ensuring data integrity, regulatory compliance, and timely execution.
This case highlights the challenges and solutions implemented to support such a large-scale study, offering insights into best practices for suppoting high-volume central lab pathology in a dynamic and regulated environment.
Anatomic pathology is often a small component of an overall clinical trial, yet it presents a highly complex problem set in terms of study design yet highly complex area of clinical trial design.
The Eurofins Central Laboratory Pathology team strives to engage early in the study design phase, providing expert consultation to help ensure a well-structured plan and smooth trial execution. By identifying inefficiencies and harmonizing data collection processes from the outset, we contribute to improved operational outcomes and data quality.
In this case study we describe a rescue study - how the Pathology group was approached by the client concerning a large phase 3 trial already in progress with another vendor that had several complex variables and tight timelines to meet study protocol.