Clinical studies
SERVICES
Clinical studies
“Need for efficacy and safety of the product”
Bioequivalence trials (human or veterinary)
OUR SERVICES
- 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 a final report
- Consulting on any of the stages of BE trials:
- Determining the required studies (fasting, fed, steady-state…)
- Optimising 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
OUR SERVICES
- 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 a 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
For medical consultancy you need a lot of experience.
BILLEV PHARMA EAST
Do you have a question for us? Contact us and we will be happy to advise you and find the best solution for you together with you!
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Billev farmacija vzhod d.o.o.
Billev Pharma East Ltd.
2023 BILLEV PHARMA EAST
© 2023 |
Operation title: BILLEV FARMACIJA VZHOD digitalizacija
Link to the European Cohesion Policy website: www.eu-skladi.si
“The investment is co-funded by the Republic of Slovenia and the European Union from the European Regional Development Fund”. – Read more
Operation title: BILLEV FARMACIJA VZHOD digitalizacija Link to the European Cohesion Policy website: www.eu-skladi.si
“The investment is co-funded by the Republic of Slovenia and the European Union from the European Regional Development Fund.” – Read more
