The Clinical Trial Unit
The Clinical Trial Unit can perform all type of clinical trials in healthy volunteers and patients, with focus on Phase I and Phase II studies. The unit is approved and regularly inspected by the Swedish Medical Product Agency to perform FIH (first-in-human) studies.
Our clients range from large pharma corporations to small biotech companies and academia.
All studies are conducted in accordance with EU clinical trial directives and guidelines, Swedish laws and regulations, and the SOPs of the unit.
The unit has an active database containing approximately 1500 volunteers. The 1.3 million habitants in the region, allow us to recruit efficiently from a large and diverse population. Studies with patients are performed in collaboration with departments that are specialised in relevant therapeutic area.
The unit has approximately 10 employees including physicians, nurses, biomedical scientists, all well-trained in GCP and with extensive knowledge of, and experience in performing clinical trials, to ensure fast and high quality data delivery. Specialists within any field of medical healthcare can be approached for advice and/or active support.
- Fully functional hospital ward with 24 h medical surveillance/monitoring
- 12 beds, available for overnight stay
- Access to in house 24-hour emergency crash team
- Access to intensive care unit.
- Separate area for blood- and urine handling
- Refrigerated centrifuges
- -20°C and -80°C temperature controlled and monitored freezer storage
- Access to accredited laboratories at the hospital
- Access to long term biobank storage.
Facilities related to drug:
- Separate drug handling/preparation area with restricted access
- Storage area in temperature controlled and monitored room- and fridge cabinets
- Access to pharmacy at the hospital which can accommodate any kind of investigational drug.
The Clinical Trial Unit offers advisory and practical services during all steps of a clinical trial. We can assist with:
- review of protocol, with focus on design and medical aspects
- review of CRF
- preparation and/ or review of subject information and informed consent
- review of clinical reports
- perform applications regarding personal data processing , biobank etc.
The medical doctors have high experience of participating in DRMC/ SRC meetings during dose escalation studies