Our phase I facilities consist of two state-of-the-art, fully equipped units for early phase studies, our hospital-based clinic at Uppsala University hospital and our clinic at Oscar II.
In contrast to many other CROs, CTC provides in-house clinical conduct at our First-in-Human (FIH) and Phase 0-II research units in Uppsala. Our clinical research units are truly the core of our company.
This unit has 24 beds and is located, together with CTC’s head office, next to the hospital. At this research unit we offer Phase 0-IV studies, for example bioavailability and bioequivalence studies.
Our 12-bed, First-in-Human unit, Akademiska, is perfectly located adjacent to the ICU, PET-centre and MRI-facilities at Uppsala University Hospital in Sweden.
Safety always comes first when planning, managing and running a First-in-Human study. CTC has experience in setting up adaptive FIH umbrella protocols including single and multiple ascending dose cohorts, food and drug-drug interaction parts, and patient cohorts. Regardless of the complexity of the study, safety is always a key focus. We conduct approximately five FIH studies a year.
Being a certified ERT-site for expert precision QT-assessments (EPQT), we may incorporate this service into your FIH study and provide the possibility for a TQT waiver.
As part of our FIH package we provide in-vitro risk assessment of immunological reactions, cytokine release and complement activation in a closed whole blood-loop system, in close collaboration with Immuneed AB.
Site Management Organisation (SMO) is a concept developed to facilitate the planning and conduct of Phase II-IV clinical trials where external or internal principal investigators may conduct studies at CTC using our systems and procedures. Our professional team of Research Nurses assist with logistics, administration, patient recruitment and clinical conduct. Our SMO site located in Uppsala (Oscar II) has all the equipment, infrastructure and experienced personnel needed to effectively support the study team.
Our educated and qualified staff consisting of Research Nurses, Physicians and Laboratory personnel constitute the heart of the clinic. We also have our own Recruitment team that constantly work with renewing our own healthy volunteer and patient database, supporting our Clinical Research Units as well as studies conducted at external clinics. As part of our recruitment, we also have a thorough pre-screening process to minimise screening failures.
Sandra Gunnarsson, Director Clinical Research Units