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