Quality Certifications

IRCCS Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia ONLUS is certified according to two interacting certification schemes:

  1. IQNet CISQ/IMQ-CSQ according to the standard ISO 9001:2008 for "Clinical trials design and management in ophthalmology and related scientific papers, " Design and provision of training courses with ECM protocol"
  2. 2. Certified Clinical Site of Excellence of the EVI CT SE (European Vision Institute. Clinical Trials. Site of Excellence) Network.

European Vision Institute - Clinical Trials - Sites of Excellence (EVI.CT.SE.) is a network of European Ophthalmological Clinical Research Sites, dedicated to perform clinical research in ophthalmology with the highest standards of quality, following the European and International Directives for Clinical Trials Research. Each Clinical Site is submitted to an On-Site Evaluation Visit by independent auditors.
The main aims and objectives of EVI.CT.SE are:

  • to guarantee a high level of quality and excellence in the work performed by the members according to ICH GCP Guidelines;
  • to serve as a resource for Industry in performing clinical trials in Ophthalmology;
  • to promote multicenter clinical research trials within the European Union;
  • to coordinate training activities for its members.