Developing & Implementing Post Market Clinical Study

RQMIS Develops and Implements a Postmarket (Phase IV) Clinical Study

The development and execution of a Post-Market (Phase IV) clinical study plays a critical role in monitoring real-world product performance while meeting post-approval requirements from regulators such as the FDA and EU MDR.

At the core of any successful study is the protocol and investigational plan—the document that guides all stakeholders, including investigators, site staff, monitors, and the clinical team. It must provide clear direction, ensure patient safety, and withstand Institutional Review Board (IRB) scrutiny.

Unlike earlier-phase trials, Phase IV studies are typically designed to be more efficient and less burdensome, allowing sponsors to gather meaningful data without the cost and complexity of full-scale clinical trials. Balancing data quality, regulatory alignment, and cost is therefore essential.

The Situation

A newly acquired medical device company needed to initiate a multi-site Phase IV clinical study in the U.S. for its FDA-cleared bone augmentation/replacement material (human tissue plus synthetic).

While the product had a broad cleared indication for use, the sponsor wanted to collect data supporting more specific clinical applications—without triggering the regulatory burden of a Phase II/III study or a new indication requiring additional approvals.

Compounding the challenge, the company had no internal clinical team to design the protocol or investigational plan, creating risk around study design, compliance, and execution.

The Solution

RQMIS stepped in as the sponsor’s outsourced clinical team, taking full ownership of study design and planning:

• Aligned with the sponsor on clinical objectives and regulatory strategy
• Engaged key stakeholders and consulted with surgeons to ensure practical, real-world study design
• Conducted literature reviews and worked with third parties to define indication-specific requirements
• Developed a protocol and investigational plan that balanced data integrity, patient safety, and cost efficiency

RQMIS collaborated closely with investigators to build both clinical and radiographic protocols, incorporating stakeholder feedback throughout. The final study design leveraged cloud-based data management tools and independent radiographic assessments to ensure high-quality, reliable data collection.

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

The Outcome

• Delivered a complete protocol and investigational plan within one month
• Achieved IRB approval with no revisions
• Selected to manage the clinical study moving forward

Straight Talk

Phase IV studies sound simple—until they’re not.

The challenge isn’t running the study.
It’s designing one that gives you usable data without triggering unnecessary regulatory burden.

That’s where this was won.