A Top Diagnostics Company Needed to Move Fast and Arete Delivered
A manufacturer of point-of-care infectious disease assays designed to deliver rapid, accurate diagnosis at the bedside.
Project overview
Arete was engaged to manage a point-of-care clinical study for a respiratory assay with an aggressive timeline: complete all study activities within a single respiratory season - despite final product labeling remaining under internal review until the last minute.
Seasonal Study Execution
Labeling-to-Launch Acceleration
Multi-Site Study Startup
Key Achievements
Accelerated Study Startup to Meet Seasonal Deadline
Arete was tasked to initiate 14 clinical sites and 3 reference laboratories during one respiratory season. In early November, our team visited the client’s headquarters and provided critical usability feedback that led to valuable product labeling updates. Final product labeling and approved study documents were received in late November. Despite the tight timeline, site initiation visits began the week before Christmas and continued through the first week of February.
Key Achievement
Arete completed two site initiation visits and enrolled five participants before the holiday break, which enabled the client to meet its internal goal of launching the study before year-end.
Client Impact
The client successfully reported study launch to executive leadership before the close of the year, meeting a key corporate milestone and reinforcing stakeholder confidence across the organization.
