Research and development services and related consultancy services

Tender description

Vision-DMD aims to advance clinical development of the orphan drug VBP 15 (vamorolone) as a new therapy to revolutionize care for all patients with Duchenne Muscular Dystrophy (DMD). The scope of this contract relates specifically to the Phase 2b randomized, double-blind, parallel placebo and active-controlled study to assess the efficacy and safety of Vamorolone in ambulatory boys with Duchenne Muscular Dystrophy and the extension study that will follow this. A registered Clinical Trial Unit (CTU) or Contracted Research Organisation (CRO) is required to set up and manage the clinical trial sites in UK/Sweden/Australia/Israel. The CTU/CRO will be carrying out delegated duties on behalf of the sponsor ReveraGen, but will be receiving payments for these duties from the Vision-DMD Horizon 2020 grant, coordinated by Newcastle University. Set up and Manage Trial in the UK as outlined in the ITT document. Set up and Manage Trial in the Sweden as outlined in the ITT document. Set up and Manage Trial in the Australia as outlined in the ITT document. Set up and Manage Trial in the Israel as outlined in the ITT document.