Clinical trial units

Clinical trial units

The clinical trial units carry out clinical studies of medicinal products, medical devices and other medical treatments, as well as other types of studies such as cohort studies. They are located at hospitals and offer access to healthcare infrastructure for clinical research such as:

• Facilities
• Accredited hospital laboratory
• Various support functions such as imaging and functional medicine
• Equipment for clinical research
• Research staff

Some of our clinical trial units conduct studies around the clock with access to:

• medical monitoring
• telemetry equipment for rhythm monitoring
• emergency team and intensive care

Experienced and extensively trained research staff

Safety always comes first when planning, managing and conducting a clinical study. The clinical trial units have experienced and extensively trained research staff with GCP training. The clinical trial units work closely with hospital clinics. Thereby they have access to specialists who can assist the clinical trial units in many different therapeutic areas. Staff at the clinical trial units may also contribute with their expertise and resources to the conduct of studies carried out at hospital clinics.

Our experienced staff at the clinical trial units in the nodes or our research support can provide following support during the planning and reporting of the studies:

• Advice and review of study protocols, case-report forms (CRFs) and reports
• Design of the research subject information and consent form
• Applications to the Ethical Review Authority and the Medical Products Agency

First-in-Human study

Clinical studies of medicinal products are divided into different phases. The first phase is called Phase 1. If this is the first time a new medicinal product is given to humans, the study is called a First-in-Human study. In Sweden, there are several clinical trial units in the healthcare system that conduct First-in-Human studies. A couple of these study units are run by the regional nodes of Clinical Studies Sweden.

Clinical trial units for first-in-Human study

Clinical trial units within the regional nodes of Clinical Studies Sweden

Please feel free to contact our clinical trial units for inquiries or further information about their services.