- Project management (incl. management of third party vendors)
- Planning of trial design & statistics
- Development of study protocols or observational plans
- Development of eCRFs and Documentation Forms
- Patient Information & Informed Consent Forms or Data Protection
- Preparation of any kind of trial-related documents
- Recruitment of investigators & study sites
- Development of patient recruitment strategies, advertisements
- Trial applications / document submission
- Patient diaries (design, validation, ePRO solutions)
- Clinical Monitoring and quantifying risk potential
- Quality assurance & management
- Pharmacovigilance activities
- Organization of scientific advisory boards
- Data safety monitoring boards
- Study report and publication writing