ZURICH, MADISON, WI, and NEW YORK (PRWEB) September 11, 2014
Three companies—one European, two American—have teamed up to allow European manufacturers of implantable ophthalmic devices to comply with anticipated regulatory demands for ongoing post-marketplace outcomes information.

In 2015, manufacturers of implantable health-related devices sold on the European market will likely be essential to offer information on the security and efficacy of their products—both prior to and now soon after their devices achieve regulatory approval. This will call for careful post-market place clinical studies to create data and reports that meet European regulators’ precise specifications.

To meet this need, a collaborative group has been formed amongst Zurich-primarily based IROC Science to Innovation AG, a major ophthalmic consulting service with specialized experience in ophthalmic clinical trials EyeKor, LLC, a firm of American clinical trial authorities that has created a cloud-primarily based application application, EXCELSIOR™, constructed specifically for supporting image data collection and management of ophthalmic clinical trials and Ethis HealthTech, LLC, an American business that serves firms in the fields of eyecare and digital healthcare by supplying marketplace-entry arranging and help, 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 substantial, so it was important to generate an efficient way for organizations to receive post-marketplace outcomes information.”

The outcome of the three-company collaboration is a turnkey resolution that provides European ophthalmic device producers a straightforward, expense-powerful way to meet the anticipated regulatory needs. This is produced possible by the joining of IROC’s in-depth understanding of the European regulatory landscape and experience 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 developed to enhance speed and accuracy in the collection and interpretation of ophthalmological clinical trial data, creating it completely suited to the quickly-to-be-required phase IV clinical outcomes studies. It is particularly designed to enable efficient uploading and archiving of pictures collected utilizing diverse proprietary instrument software program to standardize the presentation format. Excelsior™ is a software platform that received FDA 510(k) clearance with distinct indications for use as a information management method for ophthalmic clinical trials.”

As the person who engineered the collaboration, Luca Sergio, Managing Companion of Ethis HealthTech, notes: “We are pleased to join such a world-class team of recognized ophthalmic regulatory and clinical affairs experts and prime-notch ophthalmic imaging and reading center specialists to supply this robust, scalable, however easy-to-implement solution for our European business partners.”

Discover more by going to 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 solutions for translational investigation projects in ophthalmology. The company’s multidisciplinary group has more than 15 years’ expertise in ophthalmic translational research projects and brings to the table in-depth knowledge with European regulatory bodies and the design and operation of clinical trials.

About EyeKor: EyeKor, LLC, provides a complete spectrum of integrated ophthalmic clinical trial services with a network of established reading centers and clinical trial authorities. EyeKor’s proprietary application for supporting image data collection and management of ophthalmic clinical trials, EXCELSIOR™, enables image and data accessibility and progress tracking online any time, any location, as nicely as harmonization of image evaluation and grading in spite of differing instrumentation.

About Ethis Healthtech, LLC: Ethis Healthtech serves firms in the fields of eyecare and mobile/digital healthcare by supplying industry-entry organizing and support, fundraising, and strategic communications. Ethis Healthtech supports all elements of its clients’ development activities.

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Media Inquiries: 
Luca Sergio
+1-212-791-1440 (workplace)
+1-201-744-3364 (mobile)
lsergio(at)ethishealthtech(dot)com