(NU/1257) Clinical Trail Unit or Contracted Research Organisation to Set up and Manage Vision DMD Phase 2b and extension study

Tender description

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 (DMD) 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 at sites in [UK/Australia/Israel/Sweden]. 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. The contract will begin on award and end in November 2019 and be followed by an extenstion study. This contract consists of 4 separate geographical Lots: Lot 1: UK Lot 2: Australia Lot 3: Israel Lot 4: Sweden