MEDICAL AFFAIRS

Clinical studies

Bioequivalence trials (human or veterinary)

WE OFFER YOU

Clinical Overview and Summary (all legal basis applications)
Design of BE trials (protocol preparation…)
Monitoring of BE trials (on-site monitoring of BE studies execution, QA/QC)
Statistical analysis of BE trials (noncompartmental pharmacokinetic analysis and statistical evaluation)
Preparation of final report
Consulting on any of the stages of BE trials:
- Determining the required studies (fasting, fed, steady-state…)
- Optimizing design to minimize variability, e.g.:
- Blood sampling times
- replicate/semi-replicate/cross over designs
- Number and selection of subjects
- Monitoring requirements
- Statistical considerations
- Alignment with pharmacovigilance legislation

Clinical trials

WE OFFER YOU

Design of clinical trials (preparation of the study protocol including calculation of required subjects, study design…)
Monitoring of clinical trials (on-site monitoring of studies execution, QA/QC)
Statistical analysis of clinical trials
Preparation of final report
Consulting on any of the stages of clinical trials (design, conduct and analysis):
- Determining regulatory requirements for studies
- Selecting optimal study designs, including:
- Number of subjects
- Comparators
- Efficacy/safety variables
- Monitoring requirements
- Statistical considerations
- Alignment with pharmacovigilance legislation