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Regulatory Environment - Advantages in The Netherlands
Favorable regulatory conditions mean that fast timelines are still a possibility
In selecting a clinical research organization you are most certainly looking for the shortest possible timelines. The Netherlands offers an extremely supportive infrastructure, especially because
of the Dutch government's cooperative attitude to clinical research. For example, no additional procedures are required for isotope studies. Also, having no time consuming IND or CTX requirements
means that studies can actually begin within six weeks after your initial contact with us, and Phase IIa can follow Phase I without interruption. Amendments usually only require 24 hours for
Independent Ethics Committee (IEC) Chair approval. This situation compares very favorably to regulations in other countries.
IEC approval within 14 days
We handle thorough preparation of submissions of Phase I-IIa research to the IEC. Their high professional standards result in IEC approval within 14 days.
Efficiencies that save time
Because we can run several studies of a full Phase I and IIa program in parallel, we can save you even more time.
We are efficient because we have our own clinical, bioanalytical and data processing facilities, which ensure short communication lines and rapid processing of results. For example, a complete
Phase I program can be completed within five months.
Page last updated:
06 August 2008
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