AIBILI is a Research Technology Organisation in the health area dedicated to the development and clinical research to improve diagnostic, prevention and treatment strategies in order to bring better patient care to the market. It is a private non-profit organisation, founded in 1989. AIBILI is ISO 9001 Certified since 2004. AIBILI is the Coordinating Centre of EVICR.net – the European Vision Institute Clinical Research Network, a network of centres dedicated to multinational clinical research in Ophthalmology, with 101 clinical sites from 15 European countries. Three units of AIBILI will participate in this project: Coimbra Coordinating Centre for Clinical Research (4C), Clinical Trials Centre (CEC) and the Coimbra Ophthalmology Reading Centre (CORC). The 4C is a qualified structure to support investigator-initiated and industry-sponsored clinical research by providing planning and the necessary logistical support and coordination of multinational clinical research activities. It is supported in its tasks by the AIBILI Data Centre is certified by ECRIN and has experience in developing a Clinical Data Management Application, guaranteeing safety and integrity of data of multinational clinical research, compliant with regulatory requirements for EMA and FDA. The CEC performs randomized clinical trials with special emphasis on ophthalmology and has dedicated facilities and updated ophthalmological equipment. The CEC is focused in age-related eye diseases with special emphasis on diabetic retinopathy and age-related macular degeneration. The CORC focus its activities in grading retinal diseases on fundus images and OCT images of the retina, as well as functional evaluations of the retina using mfERG and visual fields. It serves as central Reading Centre for a series of multinational/multicentric clinical studies, mainly in Diabetic Retinopathy (DR) and Age-related Macular

Degeneration (AMD). The main tasks in the project will be:

• The 4C will be responsible for the overall coordination of the Clinical Study according to ICH-GCP Guidelines and European legislation. It will manage any subcontracting required for the implementation of the clinical study; liaise with other partners regarding submission and monitoring activities of the Clinical Study, as well as with all other WPs for input into data acquisition protocols, SOPs and investigator and site training.

• The CEC will be one the Clinical Sites involved in the Clinical Study for the recruitment of patients and conducting the study.

• The CORC will function as the Central Reading Centre for the ophthalmic images/examinations.

AIBILI will participate in WP1, WP3 (WP Leader), WP4 (WP co-leader) WP5, WP6, WP7, WP8, and WP9.