Clinical Trials Lease and Maintenance Program
Best Practices, Superior Clinical Tools, Industry Leading ServiceVirtually all major ophthalmic medical device and pharmaceutical companies, and many startups in the ophthalmic space, take advantage of Konan Medical’s Clinical Trials Lease and Maintenance Program. Others choose to purchase equipment outright and contract with Konan for an ongoing extended priority support and maintenance agreement to provide assurance throughout the study period. Virtually every manufacturer of ophthalmic implantable devices and pharmaceutical agents has independently assessed options for robust measures of ECD as a primary safety endpoint for FDA clinical trials, and have each chosen Konan to create these critical data points. It is not a coincidence.
Primary Safety Endpoints for Clinical TrialsMcCarey et al. lay out a number of specific recommendations for coordinating a multi-site specular microscopy study in “Review of Corneal Endothelial Specular Microscopy for FDA Clinical Trials of Refractive Procedures, Surgical Devices and New Intraocular Drugs and Solutions”. We work hard to tailor a program that helps you meet these important recommendations in a comprehensive, cost-effective, and low stress manner.
Leading Clinical Trials ProgramWhatever procurement strategy you ultimately select for your study, our goal is to partner with you to find the solution that works best for you to manage and standardize across sites in the USA or the world:
- Equipment model. All Konan non-contact specular microscopes are FDA 510(k) cleared.
- Software version. Across multiple sites and coordinate with software at reading center.
- Technician training. Konan works with many reading centers to develop detailed site instructions to standardize our technical training inclusive of documentation.
- Device calibration. On-site and delivery of appropriate documentation.
- KonanCare highest priority support. Systems are provided with permission-only remote support to troubleshoot and fix imaging and imaging issues, often while the study subject is still available on site. Equipment that requires replacement during the study is simply changed out, often next day to minimize any downtime.
Konan specular microscopes are recognized in the industry as the de facto standard for ECD determination. This is supported in the minutes from the FDA panel meeting to discuss the ARTISAN® lens: “Data from 12 sites were chosen because they used the Konan specular microscopes. This instrument is now the accepted standard for the most accurate determination of endothelial cell density”.R. Doyle Stulting, MD, PhD.
Satisfied Clinical Trials Customers
Global Reach to All Major Markets
Installation - Training - Priority Service - Study Completion
Collaboration with major CROs and Reading Centers
Can I speak with other companies that use your Clinical Trials Services?
We have many customers that have pre-approved their contact to describe why they chose Konan and to provide a reference for our services. Please note, that although virtually every manufacturer of pharmaceutical agents and ophthalmic devices does or has used our services, we 100% respect and control the confidentiality of our customer’s privacy.
What kind of clients do you work with?
Medical device, pharma companies and CROs that are collecting data to support clinical research. Fields of study may include
endothelial cell density and morphology, pupil responses and ocular-motor function, visual electrophysiology (VEP and ERG), other visual performance measures (visual acuity, contrast sensitivity), and color vision diagnostics (acquired and genetic).
A broad range of product clinical trials have and are currently being supported by Konan including: IOL, ICL, glaucoma shunts, glaucoma treatments, injectable therapies, cornea lamellar procedures, intra-corneal inlays, refractive surgery, phacoemulsification, and many others.