We realize your national and international clinical studies
(Phase I-IV / NIS) according to AMG / MPG and ICH-GCP.
- 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
- 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
- Onsite-Monitoring, Remote-Monitoring
- Site Initiation
- Site Monitoring
- Close Out
- Data Management
- Statistical consultation
eCRF & CRF (Case Report Form)
- Design (Paper-CRF)
Handling of IMP
- IMP blinding
- Logistics, IMP disposal
- Storage (regular and special needs, i.e. cooled)
- 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
We are looking forward to your request.