All aspects of
- Project Management Preparation of Project Plan and Study Operations Manual, Supervision of project finance, Management of 3rd party vendors and subcontractor etc.
- Study-Preparation Compilation and Verification of documents for regulatory submission, Preparation of patient information sheets and informed consent documents, Ethics Committee submission etc.
- Monitoring/Co-Monitoring, all types of monitoring including preparation and follow up in Germany, Austria, German-speaking Switzerland and all English-speaking Countries.
- Study Closure, Notification to the authorities of study end, archiving etc.
According to the local laws and required regulations to accomplish
international clinical trials (e.g. ICH/GCP, AMG, etc.)