• WP5 will coordinate all clinical trial activity to ensure that the robust and ethical testing of Infacort® will lead to a safe and efficacious product for children from birth up to the age of six years old.

  • Work Package 5

    WP5 is led by Charité - Universitätsmedizin Berlin and supported by Diurnal Limited.. Clinical trials in the neonatal population require specific expertise and specific facilities. The trials will be carried out by appropriately trained investigators, medical staff and nurses. These clinical trials also require the efficient collaboration between different partners in order to develop common methods of working with specific attention to quality assurance, facilitation of recruitment and ethics. The clinical centres will be monitored to ensure that high quality standards are maintained.

  • Work Package 5

    • 5.1 Establishment of clinical trials management board
    • 5.2 Complete pharmacokinetic, dose ranging and safety studies in healthy adult volunteers
    • 5.3 Complete studies in neonates and patients suffering from Adrenal Insufficiency and report clinical trial results
    • 5.4 Carry out the required pharmacovigilence, monitoring, quality control and quality assurance
  • Work Package 5

    Deliverables
    Status
    Clinical Trials Management Group
     
    Clinical Protocols and Operating Procedures
     
    Infacort® Formulation PK Trial
     
    Infacort® Neonate & Infant Trial
     
    Interim Analysis
     
    Trial Reporting