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

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

Monitoring

• Onsite-Monitoring, Remote-Monitoring
• Pre-Trial-Assessment
• Site Initiation
• Site Monitoring
• Close Out

Quality Management

• SOP-generation
• Audits

Statistical Analyses

• Data Management
• Statistical consultation

eCRF & CRF (Case Report Form)

• Concept
• Programming
• Design (Paper-CRF)

Handling of IMP

• IMP blinding
• Logistics, IMP disposal
• Packaging
• Labeling
• Storage (regular and special needs, i.e. cooled)

Pharmacovigilance

• Systematic inquiry (Literature and Authority Documents)
• Evaluation and coding of medical terms
• Legally required cumulative reports (i.e. PSUR / DSUR, RMP)
• Product consultancy hotline (24/7 if required)
• Experience in with Medical Device Vigilance