Our Service
Clinical research is the fundamental basis of medical progress. It is a long way from the initial idea to the commercialization of a drug or a medical product. Following the completion of the pre-clinic stage, ikfe CRO will accompany you with professional support from phase I onwards – from research to market launch, or to indication expansion if deemed necessary.
Pre-Clinic
- Idea
- Screening or chemical synthesis
- In-vitro experiments: concept evaluation
- Toxicology
Clinic
- Phase I – first human dose (first-in-man study, PK/PD studies, bioavailability)
- Phase II – proof of concept studies
- Phase III – safety and efficacy studies
Market authorization
- Application for market authorization
- Scientific conferences, publications, marketing and sales
- Phase IV – marketing / post-authorization safety studies / indication expansion
Preparatory - Implementation - Completion
No less challenging is the development of a medical product. With our service portfolio we can offer you almost any assistance during the lifecycle of your medical product.
Project preparatory phase
- Protocol
- Trial site selection
- CRF design
- Regulatory / authority proceedings
- IRB / Ethical Review Board proceedings
Project implementation phase
- Begin of clinical trial / study
- Monitoring
- Data management
Project completion phase
- Data base close
- Analysis / statistics
- Reporting




