Located between the central intensive care unit and the neuro intensive care unit, CTCs phase 1 unit is perfectly located at Akademiska University Hospital in Uppsala. The staff at CTC has a wide experience from early clinical studies.
Emergency training: All the staff at CTC (also including temporary staff) has a yearly heart / lung resuscitation training (HLR) using a semi-automated defibrillator.
Emergency equipment: The unit is equipped with a standard emergency cart including a defibrillator. A full specification list of the cart content can be sent on request.
Intensive Care Unit: In case of a medical emergency that requires intensive care support CTC has a written agreement with the intensive care unit at the Akademiska University Hospital. CTC is connected to the hospital’s internal hot-line phone system, which is used in case of an emergency at any clinic at the hospital. When the internal emergency number is called CTC will get support from an intensive care team within 3-5 minutes.
Laboratory Safety: Local accredited Hospital Laboratory for analysis of samples. The advantage with this laboratory is that we are connected to the lab via the hospital’s pneumatic dispatch system. This ensures a quick handling from the laboratory when CTC is sending samples that need quick analysis and response.
Healthy volunteers: CTC have access to a large pool of healthy volunteers (both male and female) in our own database in which volunteers can register interest in participating in clinical trials.
CTC is exploring new techniques for risk mitigation.
Pharmacolog AB has developed a system that can prevent drug administration errors reaching the treated patient. The company’s lead product, DrugLog®, focuses on the quality assurance in drug administration in the hospital pharmacy and the clinical ward
Pharmacolog AB is a medical device company based in Uppsala, Sweden. The company specializes in providing quality assurance solutions for safe administration of medical drugs.
- With this technique we can easily check if the provided drug is diluted correctly before administration to a subject, Folke Sjöberg, Chief Medical Officer CTC
Immuneed AB provides a first-in-class human whole-blood assay for measuring drug-related immunotoxicity and immune efficacy of mAbs and other immune modulating drugs prior to first-in-human drug trials. All based on a unique human whole-blood assay.
- With this technique we can test if a human healthy volunteer will have an immune reaction in an ex-vivo set-up before we give the drug to the subject, Folke Sjöberg, Chief Medical Officer CTC
Regulatory timelines: The review time for the Medical Products Agency (MPA) in Sweden is approximately 30 – 35 days. The MPA will either approve / disapprove / or have questions regarding the clinical study. If they have questions the CRO / Sponsor gets approximately 10 days to respond. The maximum time for approval is 60 days from the initial submission. “The clock never stops” which means that the response time from the CRO/ Sponsor is included within the 60 days. The local IRB has meetings every second week in Uppsala, it is required that we submit the protocol 3 weeks before the meeting. It normally takes 7 days until CTC receives the response on the submission. In total it takes about 5 – 6 weeks to get an approval if the committee does not have any objections or questions regarding the study.
We can offer:
First time in Human Studies
SAD and MAD studies, combined within the same protocol
TQT studies combined in FIM or separate
Food Interaction studies
Functional Food studies
Bioequivalence studies, Biosimilar Studies
Microdose Studies both with PET technique and Microdialysis