cr.appliance prepares for many pharmaceutical companies successfully drug development concepts and study designs and since more than 10 years cr.appliance is familiar with all aspects of planning, running, monitoring and examination of clinical studies.
Study design & concepts
- Proof of concept (PoC) studies
- Proof of principle (PoP) studies
- Proof of mechanism (PoM) studies
- Drug-drug- and food-drug interaction studies
- First-in-man studies
- Bioequivalence studies
- Studies with orally and nasally inhaled products
- Studies with novel formulations
Study protocol conception and writing
- Planning and design of pharmacokinetic and pharmacodynamics assessments
- Planning of bioanalytical support
- Risk-benefit assessments
- Assessment and selection of methods
- EC-submissions
- Medical contributions to IMPD submissions
- Subject / patient informed consent writing
- Writing of study related manuals
Study oversight and conduct
- Medical monitoring
- Role of study responsible physician
- Investigator & clinical team training
- Supervision of investigator’s & study teams at clinical sites
- Co-operation in and / or management of a data monitoring committee (DMC) or data and safety monitoring board (DSMB)
- CRO & vendor selection