Clinical Trials Lease and Maintenance Program
Best Practices, Superior Clinical Tools, Industry Leading Service
Primary Safety Endpoints for Clinical Trials
Leading Clinical Trials Program
- 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”.
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.