Imaging biomarker in the clinical trial
A high level of technical expertise for acquiring, analysing and processing the imaging data is required at clinical imaging centres in general.
Moreover, for clinical PET studies GMP compliance is mandatory for human administration. There are not many qualified PET imaging centres in the world which complies with all requirements and are actually conducting clinical PET studies on a regular basis.
In the field of CNS (Central Nervous System), the Karolinska Institute (Sweden), Imanova (UK) and Zürich University Hospital (Switzerland) are some of the qualified and competent centres. The Karolinska Institute in Stockholm in particular has developed and holds many radio ligands (PET Tracer) for molecular neuroimaging and is equipped with a high resolution PET system (Siemens, ≤1,5mm).
CROs (Clinical Research Organizations) play an important role in the multicentre setting in PET clinical trials. It is important for pharmaceutical companies to collaborate with an experienced CRO in order to assure the standardization process and its implementation at each centre. The CRO will be then responsible for verification of data and its statistical analysis. TFS (Sweden), Icon, ABX-CRO, Parexel, Synarc, Quintiles and Micron (domestic) are the CROs with a proven know-how in the field of PET imaging studies.