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.
In 2015, manufacturers of implantable medical devices sold on the European market will likely be required to provide data on the safety and efficacy of their products—both before and now after their devices gain regulatory approval. This will require careful post-market clinical studies to generate data and reports that meet European regulators’ precise specifications.
To meet this need, a collaborative team has been formed between Zurich-based IROC Science to Innovation AG, a leading ophthalmic consulting service with specialized expertise in ophthalmic clinical trials; EyeKor, LLC, a company of American clinical trial experts that has developed a cloud-based software application, EXCELSIOR™, built specifically for supporting image data collection and management of ophthalmic clinical trials; and Ethis HealthTech, LLC, an American company that serves firms in the fields of eyecare and digital healthcare by providing market-entry planning and support, fundraising, and strategic communications.
According to IROC’s Founder and CEO Michael Mrochen, PhD, “The burden that the proposed regulations will place on the makers of implantable devices is significant, so it was important to create an efficient way for companies to obtain post-market outcomes data.”
The result of the three-company collaboration is a turnkey solution that gives European ophthalmic device manufacturers a simple, cost-effective way to meet the anticipated regulatory requirements. This is made possible by the joining of IROC’s in-depth understanding of the European regulatory landscape and expertise in clinical trial design and operation with EyeKor’s unique clinical trial management software.
EyeKor CEO Christopher J. Murphy, DVM, PhD, notes: “Excelsior™, EyeKor’s unique ophthalmic clinical trial software platform is designed to enhance speed and accuracy in the collection and interpretation of ophthalmological clinical trial data, making it perfectly suited to the soon-to-be-needed phase IV clinical outcomes studies. It is specifically designed to enable efficient uploading and archiving of images collected using diverse proprietary instrument software to standardize the presentation format. Excelsior™ is a software platform that received FDA 510(k) clearance with specific indications for use as a data management system for ophthalmic clinical trials.”
As the person who engineered the collaboration, Luca Sergio, Managing Partner of Ethis HealthTech, notes: “We are pleased to join such a world-class team of recognized ophthalmic regulatory and clinical affairs experts and top-notch ophthalmic imaging and reading center specialists to offer this robust, scalable, yet easy-to-implement solution for our European industry partners.”
Learn more by visiting booth A11 at the 2014 Annual Meeting of the European Society of Cataract & Refractive Surgeons, September 13-17, in London, or go to phaseiveyecarestudies.com.
About IROC Science: IROC Science to Innovation AG provides consulting services for translational research projects in ophthalmology. The company’s multidisciplinary team has more than 15 years’ experience in ophthalmic translational research projects and brings to the table in-depth experience with European regulatory bodies and the design and operation of clinical trials.
About EyeKor: EyeKor, LLC, offers a complete spectrum of integrated ophthalmic clinical trial services with a network of established reading centers and clinical trial experts. EyeKor’s proprietary software for supporting image data collection and management of ophthalmic clinical trials, EXCELSIOR™, enables image and data accessibility and progress tracking online any time, any place, as well as harmonization of image analysis and grading despite differing instrumentation.
About Ethis Healthtech, LLC: Ethis Healthtech serves firms in the fields of eyecare and mobile/digital healthcare by providing market-entry planning and support, fundraising, and strategic communications. Ethis Healthtech supports all aspects of its clients’ growth activities.