Study Supply is getting more and more complex !
International procurement of comparators for clinical studies is getting increasingly difficult.
Both, tactical ad confidentiality aspects are concerned and are additionally accompanied by difficulties in blinding, availability, lead times, customs requirements and last but not least costs.
Do you know, for example, what an AZT means in german customs offices or what the difference between an active and placebo is with regard to customs regulations ? How packaging for parallel-group designs differ from such for cross-over designs with regard to customs regulations ?
Try it without the respective knowledge and you are about to loose your competitive advantage by time wasting.
We are acting as qualified and specialised brokers for comparator procurement and are authorised to import (and release, if necessary) directly based on our respective authorisation and license.
Apart from these practical aspects some of our clients asked us to act as experts in the field in writing.
We have been writing a lot of "Advisory Expert Opinions" on particularly detailed and tricky import and release situations related to IMP procurement and comparator sourcing issues.
Nearly all of the questions adressed in this context could not be answered by just asking aunt Google or any of the common ressources in the Internet.
We are exactly naming the regulations, ressources and current situation in a lot of countries within and outside EU worldwide, then. We are making recommendations on how to proceed (and mostly our clients follow our advice ;-).