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 
ikfe CRO GmbH
Bahnhofstraße 8 a
55116 Mainz
Deutschland
Telefon: +49 6131.327 90-0