Konan is Preferred for Clinical Trials

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Clinical Trials Program

Why Konan is Preferred

Specular microscopy presents challenges to medical device clinical trial sponsors. Konan is taking the initiative to identify and address the prevalent problems associated with managing specular microscopy during clinical trials, and help you, the medical device clinical trial sponsor, manage and control this essential part of your trial with a high degree of confidence.

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For a small initiation fee and a monthly charge, Konan provides each study site with:

Standardized specular microscopy platform on a rental basis
All clinical sites within a study use the same model microscope and software version.
Complete logistical support
Sponsor only needs to identify sites and inception date
Installation by a certified technician
Konan provides supporting documentation
Training by a certified technician
Konan provides supporting documentation
Calibration at site inception and periodically thereafter
Konan provides supporting documentation
Training of clinical monitors in both image capture and analysis techniques
(on request)
Remote verification of image quality and technician proficiency (on request)
Coordination with reading center to ensure that image transfer is being performed correctly
Full priority service and maintenance throughout the term of the study
End of study movement or sale of equipment to site.
End of study source data disposition – ownership of minicomputer can be transferred to sponsor and computer can be stored at site
Security key providing access control to computer/database
Program is available worldwide (local regulatory approval permitting)

Konan’s clinical trial program gives medical device and pharmaceutical companies full access to the latest, 510(k) cleared specular microscopes without the headaches associated with equipment ownership, such as transportation, storage, calibration, maintenance, etc. Installation, calibration, training and servicing are done correctly, consistently and variably, and are fully documented.

Konan Clinical Group
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T: +1 (310) 383-9050

Konan Quote

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.