Your Web-based Platform for Generating Outcomes Data to Meet European Regulatory Requirements
The looming demands of European regulatory agencies for post-market outcomes data means that device companies in the eyecare space must be able to generate quality data that will be acceptable to regulators.
If companies are to meet the need for accurate, cost-effective clinical data—both before and after device approval—they must be able to execute efficient clinical investigations that can generate the clinical data and structured reports regulators will soon demand.
To support device makers in meeting this challenge, IROC Science and EyeKor have developed a solution designed to meet specifically the challenges of post-market surveillance. This solution is based on IROC Science’s 15 years of ophthalmic clinical and regulatory expertise combined with an innovative cloud-based software platform, Excelsior™, developed by EyeKor.
For accuracy we offer a proven testing methodology, and for efficiency we incorporate a unique cloud platform that allows us to work quickly and cost-effectively. The IROC-EyeKor platform:
- was developed by some of Europe’s experienced ophthalmic clinical study design experts with decades of ophthalmic regulatory understanding and experience under their belts
- is easy and quick to implement
- provides best-in-class ophthalmic image management and data handling for rapid, accurate on-time studies
- is economical and scalable, from small to large Phase IV studies
- costs significantly less than dedicating an internal team
- provides a pre-validated data flow
- is auditable, with full data traceability
EyeKor’s Excelsior™ software platform is unique in having received FDA 510(k) clearance with specific indications for use as a data management system for ophthalmic clinical trials
Michael Mrochen, PhD
CEO, IROC Science to Innovation AG
Mobile: +41 (0) 79 746 55 25
Mark Talary, PhD
CTO, IROC Science to Innovation AG
Mobile: +41 (0) 76 582 41 50
Who we are
IROC Science, founded by Prof. Dr. Michael Mrochen, is specialized in providing consulting services for translational research projects in ophthalmology, in which IROC has provided high quality management and oversight of projects to optimize clinical strategies whilst ensuring excellence and compliance. Our multidisciplinary team, with its unique know-how, has over 15 years experience in ophthalmic translational research projects. Its strong understanding of the commercial and strategic needs required for success enables IROC to provide a collaborative and insightful approach to its partners in a cost effective fashion.
It is our pleasure to work with people that share our passion for new technologies to improve ophthalmic devices.
Ethis Healthtech, LLC, serves early-stage and emerging firms in the fields of eyecare and mobile/digital healthcare by providing market entry planning and support, fundraising, and strategic communications. 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.
EyeKor, LLC, is a network of established reading centers and clinical trial experts that offers a complete spectrum of integrated ophthalmic clinical trial services (from preclinical to clinical phases I-IV). EyeKor experts are unified through common standard operating procedures (SOPs), quality control and assurance, regulatory compliance, and computing infrastructure. Our expertise encompasses a diverse array of ophthalmic testing methods including fundus photography and angiography, optical coherence tomography, fundus autofluorescence imaging, automated visual field testing, and electrophysiological testing.