During early clinical development work, regulatory differences throughout the world have great impact on the timeframe for making “go/no go” decisions. We know that 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. That’s why the world-class Kendle Clinical Pharmacology Unit is strategically located on the campus of University Hospital Utrecht.

This high quality unit includes a 48-bed facility plus visit area with onsite project management, recruitment and screening, sample handling, pharmacy (GMP), quality control, clinical data management, biostatistics and medical writing, a Phase IIA team and independent CQA. All staff are of a senior level and are experienced in running Phase I trials.

We carry out early human administration of your compound with unsurpassed 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 – exactly the type of robust results you need.

A faster phase
The Kendle Clinical Pharmacology Unit in Utrecht, The Netherlands was recently responsible for testing a new drug for post-operative sedation in healthy subjects. Anesthetists from the academic hospital on the same campus were involved actively in the medial management of this study and gained significant experience of the effects of the drug in humans. Due to the highly favorable regulatory environment in The Netherlands, they were able to start the Phase II study in post-operative cardiac patients two weeks after the end of the volunteer study. The drug was successfully registered with the FDA several months ahead of schedule.