ZURICH, MADISON, WI, and NEW YORK: September 8, 2014 — Three companies—one European, two American—have teamed up to enable European manufacturers of implantable ophthalmic devices to comply with anticipated regulatory demands for ongoing post-market outcomes data.
Read MoreImaging is becoming an ever more critical aspect of ophthalmic clinical trials. To begin with, the number of new imaging modalities available to evaluate ocular structures is exploding. Using imaging to gauge the impact of an intervention on appropriate ocular structures allows trial sponsors and regulatory officials to determine both the efficacy of the intervention and its potential to cause harm. As a measure of both safety and efficacy, imaging has become central to today’s ophthalmic clinical trial process.
Read MoreDevelopers at EyeKor, LLC, have introduced real-time reporting of key clinical trial performance metrics in EXCELSIOR™, the company’s clinical trial data management and image analysis software.
Read MoreIn ophthalmic clinical trials aimed at achieving regulatory approval—particularly those where tissue morphology is a primary outcome measure—standardized, masked, and controlled image analysis is essential to the validity and credibility of the results.
Read MoreIf you are involved with a clinical trial for an ophthalmic product, you’re likely capturing and analyzing image data as part of your study. Which brings up a problem: Collection and interpretation of image data is one of the most challenging aspects of a clinical trial.
Read MoreEthis Healthtech, LLC, serves early-stage and emerging firms in the fields of eyecare and mobile/digital healthcare by providing strategic communications, market entry planning and support, and fundraising. Working with both pre-revenue and later-stage firms, the Ethis Healthtech team can draw upon decades of experience in ophthalmology and optometry, technology and commercialization, construction of go-to-market strategies, management of sales teams, and implementation of all aspects of marketing and communications. With a deep network among ophthalmic and digital health multinationals, clinical key opinion leaders, and investors, Ethis Healthtech supports all aspects of its clients’ growth activities.
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