Phase I, CNS
“The Trans-Atlantic Collaboration”

A major US pharmaceutical company wanted to assess the safety, and to prove the principle, of its new CNS drug using PET and MRI scans. The objective of the study was to measure the "time on target" of the investigational radiopharmaceutical and to correlate the clinical data with laboratory data and dosage. The design of the study was very complex and the number of subjects required was to be determined by the results of a real-time basis. TFS Phase I Unit at Karolinska University Hospital is one of the few facilities in the world that can provide PET scanners and undertake micro-dosing studies. In this trans-Atlantic collaboration, TFS was entrusted to develop the CRF, receive regulatory approvals, manage and monitor the study and ensure recruitment within the stipulated time frame. TFS' close relation to the PET Unit at Karolinska University Hospital ensured that all the PET (6 scans per subject) and MRI scans were completed on time and without hindrance. Furthermore, neither internal nor external audits discovered any objectionable findings in the study.