Project Management
- Study design and protocol development
- Feasibility analysis incl. screening of sites for national and international studies.
- Selection and recruiting of sites.
- Submission to authorities (BfArM/PEI) and ethics committee.
- Federal Office for Radiation Protection (BfS)
- Contract Management, Payment Management, investigator fees
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Medical Writing
- Protocols & Amendments
- Study Reports according ICH E3
- Peer-reviewed publications and posters
- Observation sheets
- Patient related documents: Development of Informed Consent Forms (ICF) and questionnaires.
- Trial relevant translations
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Monitoring
- Onsite-Monitoring, Remote-Monitoring
- Pre-Trial-Assessment
- Site Initiation
- Site Monitoring
- Close Out
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Quality Management
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Statistical Analyses
- Data Management
- Statistical consultation
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eCRF & CRF (Case Report Form)
- Concept
- Programming
- Design (Paper-CRF)
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Handling of IMP
- IMP blinding
- Logistics, IMP disposal
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Pharmacovigilance
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