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Customer Success Story: Premia Spine Accelerates Real-World Data Collection with Captivate® EDC

About the Customer

Premia Spine is a medical device company with U.S. operations in
Norwalk, Connecticut. The company designs and manufactures
advanced spinal implant systems that help surgeons treat
degenerative spine conditions while preserving natural motion.

Premia Spine’s mission is to improve surgical outcomes and enhance
quality of life for patients with chronic back pain through innovation in
motion-preserving spinal technologies.

Learn more at www.premiaspine.com.

The Challenge
The Solution
The Results

The Challenge: Scaling Global Studies and Meeting Regulatory Expectations

Premia Spine is conducting clinical research programs to evaluate the safety and effectiveness of its innovative spinal stabilization systems in real-world settings. As part of this effort, the company launched a retrospective outcomes study in France involving more than 300 patients, collecting both clinical and patient-reported outcome measures (PROMs) to support submissions to French health authorities.

“Our goal is to collect meaningful data on the use of our treatment in a French-speaking population,” said Jeff Withrow, Vice President of Clinical Affairs and Reimbursement at Premia Spine. “Before this study, there was no published literature on the safety or effectiveness of this surgical technique in that region.”

With studies expanding internationally, Premia Spine needed a flexible and validated electronic data capture (EDC) platform that could support both retrospective chart reviews and the prospective collection of patient-reported data. Traditional systems were either cost-prohibitive or too complex for the company’s multi-center, multi-country study model.

The Solution: Captivate® and the Weidley's Wish Program

"The Captivate system stood out because of its ability to facilitate the collection of validated PROMs through email or SMS. That capability was a key selling point for us."

Jeff Withrow
Vice President of Clinical Affairs and Reimbursement at Premia Spine

Premia Spine partnered with ClinCapture through its Weidley’s Wish initiative, which provides affordable access to the full-featured Captivate® EDC system for emerging and mission-driven organizations. This partnership allowed Premia Spine to implement a compliant, validated, and configurable EDC system within budget and without compromising on functionality.

The clinical affairs team also leveraged Captivate’s Virtual Data Capture (VDC) feature to offer both manual and electronic data collection options for research teams and patients. This flexibility made it easier to adapt to site preferences and local workflows across international study sites.

Nicole Calabrese, Project Manager at International Healthcare, the CRO supporting Premia Spine, played a hands-on role in configuring and deploying the study. “The build was easier than I expected,” said Calabrese. “Captivate is user-friendly, easy to configure, and simple for sites to use. The feedback from sites has been very positive.”

The Results: Efficient Setup and Real-Time Oversight

With Captivate in place, Premia Spine successfully launched its first study in France and began collecting high-quality data from more than 300 patients. The system’s flexibility allowed the company to manage both retrospective data entry and prospective outcomes tracking within a single environment.

“We can manage data collection across multiple centers and studies, even in different countries, without the complexity of older systems,” said Withrow.

“Karina from the ClinCapture team was incredibly helpful throughout the build,” added Calabrese. “She always responded quickly and worked with us through every question we had.”

“We believe our technology can help providers prevent countless amputations and reduce costs to the healthcare system,” said Anuj Khandelwal, Co-Founder and CEO at Empo Health. “Captivate allows us to prove that through enabling scalable, high-quality clinical evidence.”

Looking Ahead

Premia Spine plans to expand its use of Captivate for multiple upcoming studies, including prospective, single-center trials and a large-scale international registry. These studies will strengthen the company’s clinical evidence base and further demonstrate the long-term safety and effectiveness of its motion-preserving spinal technologies.

“In the real world, the product continues to remain safe and effective,” said Withrow. “Captivate is helping us demonstrate that by collecting reliable data efficiently and cost-effectively.”

Learn more about how ClinCapture's Weidley's Wish program empowers innovators like Premia Spine to conduct world-class research at a fraction of the cost.

Visit Premia Spine Website
View Premia Spine On LinkedIn
Summary

For more a a decade, ClinCapture’s Captivate® platform has helped expand what’s possible in clinical research by simplifying the way they're conducted - enabling secure data selection, improving patient engagement and ease of participation, and regulatory compliance across the full study lifecycle.

From life-saving therapies to innovations that improve quality of life, meaningful advancements have been achieved by equipping these tools. Trusted by both globally recognized organizations and smaller, equally driven research teams, Captivate removes the operational challenges that once made running clinical trials complex and resource-intensive.

Captivate allows teams to focus on discovery rather than tedious data collection process'—so the knowledge they generate from running clinical trials can benefit patients and communities worldwide.

About Premia Spine

Premia Spine develops innovative spinal stabilization systems designed to preserve motion, reduce pain, and improve patient outcomes following degenerative spine surgery. The company’s U.S. operations are located at 11 Commerce Street, Norwalk, Connecticut 06850, supporting ongoing clinical research and regulatory programs.

Learn more at www.premiaspine.com.

About ClinCapture

ClinCapture, Inc. provides Captivate®, a cloud-based Electronic Data Capture (EDC) platform designed for clinical trials and registries. Captivate enables sponsors, CROs, and medical-device innovators to capture high-quality data efficiently and securely while maintaining full compliance with global regulations.

Through the Weidley’s Wish initiative, ClinCapture offers discounted access to its validated eClinical platform for startups, nonprofits, and small research organizations conducting meaningful health studies.

Learn more at www.clincapture.com.

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