Overview
BSC provides statistical expertise for ophthalmic devices and therapeutics, including intraocular lenses (IOLs), refractive surgery systems, glaucoma treatments, and retinal disease management technologies. Our experience spans both surgical and diagnostic ophthalmology devices.
Specialized Capabilities
Visual acuity endpoint design (ETDRS, logMAR). Handling of inter-eye correlation in bilateral studies. Non-inferiority margin justification for ophthalmic devices. Intraocular pressure modeling for glaucoma devices. Retinal imaging endpoint assessment.
Regulatory Experience
We understand ophthalmology division expectations for vision endpoint assessment, including appropriate vision testing protocols, handling of fellow-eye effects, and long-term safety monitoring for implantable devices. Our team has successfully navigated discussions around appropriate comparators and study designs.
Representative Studies
- Intraocular lenses, IOLS, (monofocal, multifocal, toric)
- Laser refractive surgery systems
- Retinal treatment devices and drug delivery systems
- Glaucoma drainage devices and minimally invasive procedures
- Ophthalmic diagnostic imaging devices
Regulatory-first biostatistics
Support built specifically for FDA-facing programs, from early feasibility through submission and post-market requirements.
Direct communication, faster turn around
Our biostatisticians write the SAP and run the analysis. One person owns both — no separate programmer, no project manager in between.
Versatile Solutions
Engage us for a focused analysis or a full submission, We size the work to the problem.
Proven FDA Experience
Hands-On Experience with FDA Pathways, statistical reviews, and regular interactions, reducing risk and rework.
WHAT CLIENTS SAY
“They listen the first time. I’ve never had to go back and respell out what I needed."
”They work to understand the problem and leverage the information that is already there.”
Former FDA Regulator
WHAT CLIENTS SAY
"Battle ground tested."
"There is nothing that David and team haven’t seen over the years – the good, bad, and ugly.”
Vice President, Clinical Operations
WHAT CLIENTS SAY
"Get stuff done when you have to do something no one else has done before."
"They aren’t afraid to tackle difficult scenarios in compressed timelines."
CEO, Medical Device Company
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