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The Netherlands currently provides one of the most favorable regulatory environments for “proof of concept” or “proof of principle” studies: there is no central regulation of any clinical trials, and an experienced ethics committee facilitates regulation. Our dedicated Clinical Pharmacology Unit (CPU) is strategically located on the campus of University Hospital Utrecht, and that’s one of the reasons why 13 of the world’s top 20 biopharmaceutical companies have utilized our CPU.
We carry out early human administration of your compound with precision, using our highly qualified experts, large subject database of healthy volunteers, special populations, and state-of-the-art technologies. Our collaboration with the academic hospital departments gives us additional access to expertise and patient populations, all of which ultimately accelerates your drug development process. Data generated by this unit are wholly acceptable by the FDA
and other global regulatory agencies. Click here to discover more about our CPU.
Kendle's clinical pharmacology services include:
- Protocol and study design
- CRF design
- First in human studies
- Pharmacokinetics
- Pharmacodynamics
- Drug metabolism
- Drug–drug interactions
- Drug–food interactions
- Data management (Oracle® Clinical; Oracle® Clinical RDC)
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- Special populations
- Drug preparation (GMP)
- AE review/reporting
- Quality assurance
- Quality control
- Statistics/report writing
- Phase I and Phase IIA
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*Oracle® Clinical is a registered trademark of Oracle Corporation and/or its affiliates
In addition to our clinical pharmacology services, Kendle in The Netherlands also provides Phase II–IV Clinical Development services. |
