What is Phase IV Eyecare Studies™? What do you offer?

A solution specifically engineered to help ophthalmic implantable device manufacturers meet EU requirements for ongoing post-market surveillance studies.


Why should I be concerned about post-market surveillance?

Manufacturers of certain kinds of medical devices, such as intraocular lenses, sold on the European market are required to provide data on their products’ safety and efficacy—before and now after their devices gain approval—according to EU medical device regulations. As a result of recent violations and failures in the medical device industry, the guidance documents for compliance are being applied more strictly and the regulations better enforced, such as by increasingly rigorous unannounced inspections. Manufacturers must be able to execute efficient clinical investigations to generate the outcomes data and structured reports European regulators are now demanding for compliance with post-market surveillance requirements. These post-market studies entail complexity, cost, and a heavy IT burden in terms of data collection, evaluation, and reporting.


What is at stake if my company doesn’t comply?

Failure to comply has resulted in products losing EU certification.


How can Phase IV Eyecare Studies™ help me comply and thrive in the European market?

Phase IV combines IROC Science’s 15 years of experience in supporting the medical device industry to bring products to market with an innovative cloud-based software platform, Excelsior™, developed by EyeKor. By uniting IROC’s ophthalmic clinical and regulatory expertise with the Excelsior™ platform (which has been cleared by the US FDA for ophthalmic clinical trial image management), Phase IV can offer highly efficient, turnkey clinical studies with output designed specifically to meet the requirements of European regulatory bodies. IROC provides the opportunity to customize your implementation of Excelsior™ specifically for today’s demanding European regulatory landscape according to your clinical needs.


How difficult is this to implement?

Our service only exists to dramatically simplify compliance with EU regulations. We provide the overall regulatory framework and study design, create electronic case report forms (eCRF) specific to your device, roll out the software platform, train your clinician investigator sites, manage the phase IV trial itself, and provide period reporting so that you can fill your management file with the reports required by the notified bodies. You will not need to add staff to manage this complexity. That is our role.


How can Phase IV make day-to-day trial management easier?

With Excelsior™, you no longer face a “black box” when determining how your trial is progressing: the homepage dashboard features an easy-to-read compliance graph displaying the number of protocol deviations and adverse events, how the data verification and source validation are advancing, and the status of patient flow, including which patients are due for visits and whether or not they have been contacted.


How can Phase IV make data reporting easier?

Unlike other electronic data capture systems, Excelsior™ allows for image and eCRF data to be read and analyzed on the same platform. Access to the combination of these images and data, as well as the total traceability from images to measurement to data, enhances the power of analysis provided to the user by the Excelsior™ platform.


How can Phase IV help me manage queries from study personnel?

Excelsior™ offers a full query management system so that clinical trial sponsors can quickly and easily determine how many queries are outstanding, who is responsible for them, and when they need to be completed—all while maintaining full traceability of changes during the trial through the access management and administration features.


How can Phase IV help me comply with complex data entry requirements?

Excelsior™ provides the risk management tools necessary for complying with data entry requirements. In addition, Excelsior™ incorporates a database of contacts for adhering to communication and auditing requirements.


Can Phase IV help me audit my clinical trial?

Yes! Because auditing is an essential part of demonstrating traceability, Excelsior™ provides you with a proper tracking trail of changes in information as part of the process. You can easily identify changes in information and track the resolution of outstanding issues.


How long will it take to begin our phase IV trial?

Depending on the size and number of clinician investigator sites needed, the process—from initial consulting to having all the sites trained on the software and certified for uploading patient data—may take a few weeks to a couple of months.


What language(s) are supported by the Phase IV platform?

Currently, the Phase IV platform is for English language use, but we are investigating providing the platform in German, French, and Spanish.


What are the elements that drive the cost?

The primary variables are number of clinical investigator sites; number of patients needed; number of diagnostics used; and frequency of visits (usually pre, intra-surgery, post, 6 months, 12 months).


We are a small company and do not have deep pockets. Can we afford Phase IV?

Yes! The Phase IV platform is economical and scalable, from small to large post-market studies, and costs significantly less than dedicating an internal team.


I’m interested in exploring the Phase IV solution. What are the next steps?

Contact Luca M. Sergio at LSergio@ethishealthtech.com or by phone at + 1 212-791-1440. We will schedule a time for an initial Web meeting or in-person visit. We ask that you provide us with details on your product and participate in an initial, joint brainstorming session on trial design. Then, you can view our demonstration on the Web SAAS platform and the price quote, which we will calculate based on your input. We are ready to execute a non-disclosure agreement as you may require.