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SAON | Unified MedTech & Site Management Solutions
From First-In-Human to FDA Submission with Confidence
Helping an early-stage spine company navigate its first study
The Challenge
A promising new MedTech company had developed an innovative interbody fusion device, but they had no internal clinical team and no prior experience running a study. They were preparing for their first-in-human trial and needed more than just a CRO. They needed a partner who could help them design a strong protocol, select the right sites, manage the entire clinical process, and ultimately generate submission-ready evidence for regulatory review and market entry.
They had the technology. SAON brought the strategy, structure, and execution.
How SAON Helped
Clinical Strategy and Protocol Development
From the beginning, SAON served as a trusted clinical advisor. We helped shape the study design, refine inclusion criteria, define primary endpoints, and plan for long-term follow-up with a clear line of sight to regulatory success. Our team worked closely with the sponsor to build a study that was both scientifically sound and operationally achievable.
Site Identification and Study Start-Up
We activated three high-performing spine surgery sites from our network, even though none had prior experience with MedTech research. SAON managed every step of the process, including feasibility, contracting, budgeting, and IRB approvals. We also provided the on-site support needed to ensure smooth activation.
Full-Service Study Management
Throughout the study, we handled day-to-day coordination, ensured protocol adherence, configured the eSource system, and delivered ongoing training. Our centralized oversight helped prevent delays, ensured clean data, and created a stress-free experience for both the sponsor and the investigators.
Regulatory and Evidence Support
Once enrollment was complete, we prepared the full clinical study report, supported the FDA submission, and helped the sponsor develop abstracts, posters, and peer-reviewed publications. We also offered strategic guidance for communicating with payors and preparing for commercialization.
What We Delivered
- Three successful study sites activated and managed from start to finish
- Zero major deviations and on-time enrollment
- Submission-ready clinical data for FDA and payors
- Conference presentation and peer-reviewed publication completed post-study
- Comprehensive support for commercialization and reimbursement strategy
Why It Mattered
This sponsor had never run a study before. By partnering with SAON, they not only launched their first clinical study but executed it at a level typically seen from much larger organizations. Our team delivered the structure, expertise, and long-term support they needed to move from concept to credibility.
Ready to Get Started?
Schedule a call with our team to learn how SAON can help your next study succeed, no matter where you are starting.
