ALLOCATION & RANDOMISATION

For manual randomisation setups Nomeco CTSM acts as central call center; setting up, coordinating and handing out randomised blinded treatment for subjects in clinical trials throughout the entire study. Site staff can access randomisation numbers in an easy, blinded and secure way, so each subject gets randomised to their intended treatment.

The allocated IMP will be sent to the site together with code break envelopes, which is packed by Nomeco CTSM. Additionally, Nomeco CTSM offers to allocate the blinded trial product to each of the subjects, calculating trial product forecast and overseeing that all sites have sufficient products for incoming visits throughout the study lifetime. Setup of trigger level, minimum and maximum buffer and resupply weeks will be agreed with sponsor before initial IMP is shipped to site.