Phase I clinical trialsThe demand for Phase I services is increasing around the world, as an expanding range of biopharma companies seek to test new compounds and biologics in well- controlled first-in-man studies. These require access to a well-informed population of healthy volunteers or patients (oncology), together with approved quality facilities and an appropriate level of experience and medical monitoring. NZ has a world-class FDA audited (& FDA-approved for electronic data storage & transfer) Phase I unit based in Christchurch (www.ccst.co.nz) and a second unit managed by the same experienced Phase I group opened in Auckland in 2007 (www.clinicalstudies.co.nz). Australia also offers world-class facilities and has Phase I units in each of the main centres- Sydney, Melbourne, Adelaide and Brisbane. Both countries do counter-seasonal work in immunology, allergies, arthritis and respiratory research, allowing development programs to advance more rapidly. BELTAS does not monitor Phase I studies as part of its European operations. BELTAS staff have international experience in Phase I studies, understanding the strict requirements of managing this intensively-monitored research.
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"Contract research organizations (CROs) provide substantial global capacity to drug developers and have become a critical contributor to clinical trial activity" - Tufts CSDD |


