Our phase I facilities consist of two state-of-the-art, fully equipped Clinical Research Units for early phase studies – hospital-based Akademiska and Oscar.
In contrast to many other CROs, CTC provides in-house clinical conduct at our First-in-Human (FIH) and Phase 0-IV research units in Uppsala and Linköping. We have two clinical research units in Uppsala, Akademiska and Oscar, and one in Linköping, Brigaden. Our clinical research units are truly the core of our company.
This unit has 24 beds and is located in conjunction 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.
In Linköping we have our late phase clinical research unit with the ability to conduct out-patient clinical trials in Phase II-IV.
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. Since 2012, we have conducted over 25 FIH studies.
Being a certified ERT-site for expert precision QT-assessments (EPQT), we may incorporate this service in 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 Study Coordinators and Research Nurses assist with logistics, administration, patient recruitment and clinical conduct. Our two SMO sites located in Uppsala (Oscar) and Linköping (Brigaden) have all the equipment, infrastructure and experienced personnel needed to effectively support the study team.
The heart of the clinic lies within our educated and qualified staff consisting of Research Nurses, Physicians and Laboratory personnel. We also have our own Recruitment team that constantly work with renewing our own healthy volunteer and patient database, supporting all 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 minimize screening failures.
Sandra Gunnarsson, Director Clinical Research Units