Consultancy & Concepts

The core competence of cr.appliance is the creation and evaluation of scientific and strategic development concepts. Due to the long lasting experience in drug development cr.appliance supplements in-house teams especially in strategic tasks.

  • concepts and counseling in drug development, especially in early phase of clinical development
  • expert assessment of drug development projects
  • advice in regulatory processes
  • preparation of and participation in hearings with regulatory authorities
  • development strategies
  • development plans
  • evaluation of methods and outcome measures (primary target values) of clinical studies
  • systematical analysis of faiied clinical studies (= scientific product rescue activities)
  • concepts and layout of clinical studies e.g.
    • proof of concept (PoC) studies
    • proof of principle (PoP) studies
    • proof of mechanism (PoM) studies
    • drug-drug-interaction studies
    • first in man studies
    • thorough QT sudies
    • studies with inhaled medicines (MDIs, DPIs,etc.)
    • bioequivalence studies
    • pharmacogenetic factors / personalised medicine (individualized pharmacotherapy

An important factor for the success of drug development is to identify problems and challenges in the development process in advance and to address them appropriately and in good time. Furthermore, in highly complex development processes, cr.appliance can mediate between the disciplines and functions, company decision-makers, authorities, and the various external service providers and consultants involved in order to achieve value- and time-optimised concepts.