The Clinical Trial Management unit provides advice and support to coordinating investigators of investigator-initiated trials. ZKS stands ready to take on any of the following tasks:

  • Obtaining a EudraCT Number
  • Protocol writing in cooperation with the coordinating investigator
  • Creating the Informed Consent form
  • Buying an insurance policy
  • Submissions to regulatory authorities and ethics committees
  • Notifications to regulatory authorities
  • Registration of the trial in a clinical trials register
  • Support in creating Case Report Forms (CRF)
  • Preparation of Trial Master File and Investigator Site File
  • Trial coordination
  • In-house review of completed CRFs and query management
  • Coding of adverse events
  • AE/SAE reconciliation
  • Support in creating the final clinical trial report
  • Assistance in manuscript preparation
  • Preparation of archiving

Contact persons