Angelika Karwoth

Independent clinical trial management and monitoring (phases I-IV) since 1996. Consultancy for submission of gene therapy studies to EC, Regulatory Authorities and other relevant committees to obtain authorisation to conduct the trial; Translation English/German

Comprehensive clinical trial management for early phase II studies in several European countries, incl. EC submissions, site selection and site set-up, preparation of Investigators Site Documentation Consultancy for submission of gene therapy studies to EC, Regulatory Authorities and other relevant committees to obtain authorisation to conduct the trial Set up and management of central lab logistics for gene therapy study