Implementing Post Market Clinical Study

RQMIS Develops and Implements a Post-Market Clinical Study

Developing and implementing a clinical study to support a new or expanded claim is essential—not only to monitor real-world product performance, but also to generate evidence that strengthens competitive positioning. These claims may include outcomes such as reduced adverse events, faster healing, or lower overall healthcare costs. While they do not change the product’s cleared indication for use, they can significantly impact market adoption.

At the center of every successful clinical study is the protocol and investigational plan. This document serves as the operational blueprint for all stakeholders—including investigators, site staff, monitors, and the clinical team—ensuring clarity, consistency, and patient safety. Because it is subject to Institutional Review Board (IRB) review, the protocol must be scientifically sound, operationally feasible, and fully aligned with regulatory expectations.

Sponsors pursuing expanded claims face a balancing act. On one hand, they aim to design studies that remain within the product’s cleared indication to avoid the added cost and complexity of an Investigational Device Exemption (IDE). On the other, they must ensure the study captures robust, high-quality data capable of supporting future regulatory submissions, such as a 510(k) or PMA supplement. Achieving both requires a precise and well-informed study design.

In this case, a newly acquired company with an FDA-cleared bone augmentation/replacement material needed to initiate a multi-site U.S. clinical study to evaluate whether its product could achieve bone fusion at a rate comparable to autograft. The study needed to begin quickly, but the company lacked an internal clinical team and required guidance on how to collect meaningful effectiveness data without triggering IDE requirements.

RQMIS stepped in as the sponsor’s clinical team, taking full ownership of protocol and investigational plan development. The approach included:

• Aligning with the sponsor on clinical objectives and regulatory goals
• Engaging key stakeholders and consulting with surgeons to ensure practical study design
• Conducting literature reviews and collaborating with third parties to define claim-specific requirements
• Designing a study that balanced data integrity, patient safety, regulatory alignment, and cost efficiency

RQMIS worked closely with investigators to develop both clinical and radiographic protocols, incorporating stakeholder feedback throughout the process. The final investigational plan included modern, efficient tools such as cloud-based data management systems and independent radiographic assessment methods to ensure high-quality, reliable data collection.

Once finalized, the protocol was submitted to participating surgeons and a central IRB.

The results:

• Clinical protocol and investigational plan delivered within one month
• Study design aligned to support future regulatory clearance
• IRB approval obtained with no revisions
• RQMIS selected to manage the clinical study moving forward