• Contract management of Phase I clinical trials (Start Unit) may be initiated at any time. To initiate the contract management, please contact the Start Unit: paloma.delgado@startmadrid.com This link opens in a popup window
  • Additionally, to register Phase I Clinical Trials, the following documents must be provided:
      1. XmlEMEA document of the initial submission of the clinical trial or documents called ‘Initial application form-EMA’ (Part 1 and part 2) that is generated when the trial documentation is submitted through CTIS.
      2. Protocol
      3. Adequacy of the Research Team to see the intended patients
      4. Insurance policy, with a list of all centers
      5. Favourable opinion of the CEIm, which has approved the trial
      6. AEMPS authorisation, if applicable.