This covers all types of activities to enable the actual start of a study, including:

  • Feasibility studies and site selection
  • Development, customization and translation/validation of study documents (e.g. Informed Consent Form, Patient’s Diary, Emergency Card, IMP label)
  • Ethics and Competent Authority submissions
  • Privacy Committee submissions
  • Site contract and budget negotiations
  • Preparation of the Investigator files and Trial Master File

As study start-up is a critical step in the clinical trial world, it often goes hand-in-hand with challenging deadlines. At Ad Hoc Clinical, we believe that involving the same team in each step of the way (and especially for submissions), significantly improves efficiency, shortens start-up timelines and reduces costs. Moreover, it allows to build positive professional relationships with the study sites and regulatory bodies from the very beginning.