FASTinov S.A. (Portugal)
A company founded in 2013 by a multidisciplinary team with expertise in (clinical) microbiology and flow cytometry assay. FASTinov focuses on development of innovative solutions in AST and in this project will develop their novel FAST-bact tests for market launch.
A company that is specialised in bio-informatics and software development, will develop a software package for easy analysis of results.
μRoboptics was founded in 2013 by senior research engineers from technical universities and software engineering professionals. With more than 10 years of research in the areas of control theory, computer vision and applied robotics, our team combines solid scientific knowledge with practical engineering spirit to deliver state-of-the-art solutions.
μRoboptics is committed to exceed expectations by bringing innovative and disruptive technologies into its services and products. Our goal is to apply core technological knowledge and expertise to solve nowadays challenges across a wide range sectors and industries.
μRoboptics actively invests in research of future technologies in the fields of computer vision and artificial intelligence. In the field of computer vision, our research team is particularly focused on 3D reconstruction, reverse modeling and object tracking. In the field of artificial intelligence, we are applying deep learning strategies to develop detectors and classifiers to automate specific tasks.
Roboptics develops innovative products and provides specialized technical consulting and research services in the areas of robotics, computer vision, biomedic technologies and engineering.
Hospital Ramón y Cajal, part of SERMAS (Spain)
Prof. Rafael Cantón is a key opinion leader on antibiotic resistance and AST and chairman of EUCAST. His group at the Clinical Microbiology Department will provide samples and expertise, and together with FASTinov will perform the final clinical validation of the tests.
Servicio Madrileño de Salud (SERMAS) is the administrative and management structure that integrates every public hospital and other public health services of the Madrid Regional Health System.
Hospital Universitario Ramón y Cajal (HURYC) is a 1,000 bed University Hospital in Madrid (Spain) founded in 1977 and affiliated to Universidad de Alcalá de Henares. It provides comprehensive health care in all medical and surgical specialities, and has a basic research department. It has an established research institute (IRYCIS) that encompasses basic, translational and clinical research departments, with all the required infrastructures to perform phase I to IV clinical trials, including full laboratory and imaging equipment and an Ethical Committee. It ranks first in Madrid and third in Spain in production of biomedical research, working in partnership with more than 50 international leading centres. IRYCIS consists of a total of 28 research groups that focus their activities on five major areas (Neurosciences; Microbiology, Immunology and Infection; Chronic Diseases and Cancer; Epidemiology and Health Technology; Cardiometabolism and Systems Pathology), as well as many other independent researchers from the clinical area. All this critical mass generates more than 600 publications per year and over 110 clinical trials. The knowledge generated by all this activity has resulted in more than 58 innovation projects, and 23 patent families. According to the last scientific report of IRYCIS, corresponding to 2016, the Institute published nearly 800 articles with an accumulated impact factor of more than 3,500. IRYCIS has a Business Development Office, giving support to all projects from their very beginning - “from the idea to the market”; this office includes one Innovation and Technology Transfer Unit as well as one International Projects Unit.
IRYCIS - Mission, Vision & Values
"To be a space dedicated to biomedical research of excellence, aimed at generating useful knowledge for the identification and treatment of current or potential diseases. Its actions are a continuous improvement with a strong vocation and translational nature to become a national and international reference.”
"To lead basic, clinical and translational scientific research as a reference for society, scientific community and public & private institutions at a national and international level."
"To contribute significantly to the generation of new knowledge, its application to the care practice, business environment and the training of new researchers in biomedicine"
Search for excellence; Leadership; Innovation and orientation to the transfer of results; Orientation to the health problems and people interests ; Basic-clinical and multidisciplinary collaboration; Technical training
Effective management; Integral quality; Professional Recognition; Dissemination Research activities
The Department of Clinical Microbiology, the operational partner in the project, has a high publication rate - a mean of 100 of impact factor/year during the last five years. It is a fully equipped Dept. with clinical diagnostic duties and molecular biology research clinically oriented (16 researchers, including 7 project leaders) and has participated in different EU-projects [ref.: DEAR-001873; COBRA-503335; EAR-518152; DRESP-0180705; ACE-037410; BIOHYPO; TROCAR-223031; PAR-241476; EVOTAR-282004; R-GNOSIS-282512; MON4STRAT-602906; IMI-ENABLE-115583; IMI-COMBACTE-CARE-115620; IMI-i-ABC-115721; JPI-EC-AMR-2016 (STARC & ST131TS)], mainly in the antimicrobial resistance area and population evolutionary biology
EuroClone Diagnostica (Italy)
A company specialized in development of specialty medical diagnostics will produce the tests in microplate format, both for clinical validation and subsequently on a large scale.
Profess Medical Consultancy (Netherlands)
A company that will monitor the validation study to facilitate regulatory acceptance of the final products.
Our mission is to assist and support pharma companies, medical technology companies and Health Care Institutions with the translation and interpretation of rules and regulations in order to comply with regulatory requirements in such a way that bureaucracy is reduced to the optimal minimum. The consultancy concentrates to the development of medicinal products, medical devices and food supplements in general and to implementation of clinical research in the organizations in particular. Our aim is to find practical solutions for difficult regulatory issues by complying with our principles to deliver accurate quality work according to the agreed objectives, to work honestly, fair and reasonable.
Our activities and expertise relate to:
• Design of custom-made clinical research quality systems for Industry and Health Care Institutions
• Independent Clinical Quality Assurance Auditing in Europe, Asia and the USA in compliance with applicable rules and regulations e.g. ICH GCP guideline, ISO 14155 standard for clinical investigations with medical devices and ISO 9001:2008 standard for quality management systems
• Consultancy in Quality Systems Management and Clinical Research
• Assisting and interim management in Regulatory Affairs for medicinal products and medical devices
• Organizing in-company Training to conduct Clinical Research in compliance with rules and regulations e.g. ICH GCP training, Training on national rules and regulations, qualification courses for clinical research personnel
• Training and education of physicians, nurses and biomedical specialists at the University of Ghent as professor
• Coaching of Clinical Research Personnel during their training and education
The following handbooks have been published recently based on our expertise, e.g.
State of the art clinical trials for medical devices
A practical hands-on compliance guide on how to conduct medical device clinical trials in compliance with prevailing international Good Clinical Practices and medical device requirements.
Quality in Nuclear Medicine
Good Clinical Practices in (Nuclear) Research.
Together these partners will work towards commercialisation of the FAST-bact tests using their complementary expertise and resources.