RQM+

Overview

RQM+ is a management consulting firm based in the United States, specializing in the business services sector, particularly in the domain of regulatory affairs and clinical trial design. Founded in 2008, the company employs between 201 and 500 individuals and has reported significant revenue. RQM+ focuses on optimizing reimbursement and market access for medical devices through comprehensive clinical study designs. Their published white paper, "Designing Clinical Studies to Optimize Reimbursement and Market Access," outlines their strategic approach to clinical trial design, emphasizing the importance of early engagement, tailored execution, and a focus on patient diversity. The document includes case studies that illustrate various trial designs, such as superiority and non-inferiority randomized controlled trials (RCTs), and discusses common pitfalls in clinical trial execution, including misalignment with regulatory requirements and suboptimal site selection. RQM+ aims to provide integrated regulatory and reimbursement expertise, ensuring that clinical studies not only meet regulatory standards but also enhance market access for medical devices.

Industry