Accelerating PLU Ophthamic’s Device Trial Through Unified Clinical and Technology Support
Background & Challenge
PLU Ophthalmic™, a small medtech company developing an ophthalmic device, faced multiple challenges as it prepared to initiate its clinical program. With no in-house clinical operations, data management, or regulatory team, the sponsor needed to launch quickly while maintaining lean oversight and cost efficiency. The complexity of the ophthalmic protocol introduced additional risks for delays and amendments, and reliance on fragmented vendor arrangements created potential communication gaps and added burden for study sites.
Sitero’s Solution
Sitero implemented an integrated delivery model that brought together Mentor EDC, CTMS, and Sitero Central IRB with comprehensive clinical operations, data management, and biostatistics expertise. Early collaboration during protocol development ensured the design aligned with both regulatory expectations and the operational realities of ophthalmology research. A single point of contact was established to coordinate communication and streamline decision-making, while automated site payments through Mentor’s EDC–CTMS integration reduced administrative workload and improved accuracy across trial activities.
Outcome
The partnership accelerated study start-up with minimal amendments and strong site engagement. Streamlined workflows enabled the sponsor to focus on research and commercialization priorities while maintaining full visibility into study progress. Site activation and enrollment targets were achieved as planned, supported by a unified technology environment that improved data quality and operational efficiency. The sponsor now benefits from a scalable infrastructure designed to support future ophthalmic programs with greater speed, control, and confidence.
Why Sitero?
This case demonstrates how Sitero’s integrated technology and operational model can help small medtech companies navigate the complexities of ophthalmology clinical trials. By combining expert guidance, streamlined processes, and full-service support, Sitero accelerated timelines and ensured operational precision.
What This Means for Sponsors
Ophthalmology studies often require specialized expertise, rapid execution, and tight coordination across sites. Sitero’s approach enables small and emerging sponsors to run efficient, compliant ophthalmic trials without building extensive internal teams—allowing them to focus on innovation and patient impact.
Testimonial
“Sitero’s integrated approach and Mentor technology reshaped our ophthalmic trial—what could have been a complex, fragmented launch became a seamless, well-coordinated study that met timelines, reduced site burden, and let us focus on advancing our commercial execution.”
Carlos A. Urrea, MD. MPH
CO-FOUNDER
PLU OPHTHALMIC
Learn how Sitero helped PLU Ophthalmic™ accelerate trial start-up through integrated clinical operations, Mentor EDC, CTMS, and IRB support.
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