For companies developing innovative spine treatments, regulatory approval is only one part of the journey. Sustaining momentum in international markets requires continued evidence, especially data collected within the populations where the treatment will be used.
For PremiaSpine, that next step meant building out structured real-world data collection in France. Led by Jeff Withrow, VP of Clinical Affairs & Reimbursement, the team is expanding its evidence base through a large retrospective and prospective outcomes study, laying the groundwork for additional studies to follow.
PremiaSpine’s treatment has already been through a rigorous regulatory pathway, including a randomized controlled trial supporting FDA approval. But as Jeff explains, health authorities in different countries want to see data from their own populations.
The goal is straightforward: collect meaningful, defensible data from a French patient population to support regulatory discussions with French health authorities.
To do that efficiently, the team needed a system that could handle validated survey instruments, support multi-site growth, and allow both manual and electronic data collection.
One common feature across virtually all of our studies is validated Patient Reported Outcome Measures. The ability to collect those electronically via email or SMS was a key selling point for us.
In other words, collecting outcomes data needed to be practical for patients and manageable for research teams.
PremiaSpine implemented Captivate® to centralize data collection for the French study and future programs.
The system supports:
Nicole Calabrese, Project Manager at their partnering CRO, helped lead the system build and site training. For her, usability mattered just as much as functionality.
The build was honestly easier than I expected. It’s straightforward and easy to use, and the sites haven’t had any complaints.
That simplicity was important. This was Nicole’s first time building an EDC system, and having something intuitive reduced friction for both the CRO and the site staff entering data.
Jeff echoed a similar sentiment about the experience from a clinical leadership perspective.
Ease of use on the researcher side is critical. The interface is straightforward and practical for day-to-day use.
The goal wasn’t complexity. It was consistency and reliability.
The French study is the first deployment under PremiaSpine’s broader 10-study roadmap. While the initial focus is retrospective and prospective data collection at a single high-volume center, the company is already looking ahead.
Captivate® gives the team a repeatable framework they can carry forward into each of these efforts.
Rather than starting from scratch with each study, PremiaSpine now has a structured environment for data capture that can scale with their clinical strategy.
Like many growing medical device companies, PremiaSpine had to balance ambition with budget.
Traditional EDC pricing models can make large-scale deployment difficult, particularly when planning multiple concurrent studies. The expansion of ClinCapture’s Weidley’s Wish program allowed PremiaSpine to implement a fully featured EDC system aligned with their financial planning.
That flexibility made it possible to move forward with structured data collection now, rather than postponing until budgets allowed.
PremiaSpine’s objective is not simply to collect data. It is to demonstrate, in real-world surgical settings, that their FDA-approved treatment continues to perform safely and effectively across different healthcare environments.
By combining structured data collection with validated outcome measures, the company is building a practical evidence base that supports long-term growth in international markets.
And with a scalable system now in place, future studies won’t require reinvention, just expansion.
