NUI Galway - RFT for the Provision of a Vaginal Atrophy Study

Tender description

The requirement is for the ‘AVeta Medical’ project, in NUI Galway, which has been funded by Enterprise Ireland, to develop a novel transvaginal device to treat vaginal atrophy in women. A U.S. pre-clinical Research Centre, which is associated to a U.S. Research University, is sought for the supply of a site and associated services to carry out the study. This is a requirement of the study to ensure future FDA approval as the U.S. is the first market to access and ‘First in Woman’ Clinical (FIW) will be conducted in the U.S. The Research Centre MUST have a team with vast expertise and experience in previous studies in reproduction and research. The U.S. preclinical Research Centre / University of Research MUST have experience in conducting pre-clinical trials in reproduction / woman’s health. The research team MUST include professors to offer expert guidance, consultation and training on the design of the pre-clinical study, the interpretation of the results data and planning for future phased studies.