- The Clinical Trial Units at Haukeland University Hospital The Clinical Trial Unit at Haukeland University Hospital consists of a section for adults and a section for children. They are staffed with GCP-trained personnel with long experience from early phase studies, and have well equipped premises for clinical studies.
- Centre for Cancer Biomarkers (CCBIO) works on new cancer markers and targeted treatment. They can help you with special analyses in your clinical study.
- Course in Good Clinical Practice (GCP) in Bergen – Good clinical practice (GCP) is an international quality standard that is provided by ICH (http://www.ich.org/home.html). The course gives you a basic knowledge to GCP and the legal framework in clinical studies. It is relevant for everyone involved in a clinical study.
- Norwegian Clinical Research Infrastructures Network (NorCRIN) offers research support in clinical studies. They can provide relevant information for everyone who plan a clinical study, and can help you to get the study started.
- Helse Norge offers an overview of clinical studies in Norway, aimed for potential patients
- Norwegian Medicines Agency (Statens Legemiddelverk – SLV) provides information about which studies needs approval, and you can send an application to get approved your clinical study.
- Application for medtech equipment – if you want to test equipment on humans in your clinical study in order to gain the certification mark “CE”, you have to apply for approval from the Norwegian Directorate of Health.
- Regional Committees for Medical and Health Research Ethics (REC) – all clinical studies must apply for a REC-approval. REC shall provide advance approval for 1) medical and health research projects, 2) general and thematic research biobanks and 3) dispensation from professional secrecy requirements for other types of research.
- ClinicalTrials.gov is a US based registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.
Are you working with clinical studies? There is a number of networks that can help you and inspire you.
- National Competence Network for Medicine for Children works to ensure that drug treatment for children should be appropriate and safe, and based on documented knowledge.
- NorPedMed is the research’s network in National Competence Network for Medicine for Children. They aim to increase the number of clinical studies/PIP (Pediatric Investigation Plans) on children. They offer five sites at the main hospitals in Norway, that are GCP trained and specially trained in working with children.
- Nordic Health Research and Innovation Networks (NRI) is an independent, non-profit organisation working to promote health research and innovation in the Nordic region.
- Nordic Nect is a cooperation between phase I cancer units in Denmark, Finland, Norway and Sweden.
- Nordic Trial Alliance is an organization initiated by NordForsk, and aims to make it easier to carry out clinical research in the Nordic countries.
- Oslo Cancer Cluster is an oncology research and industry cluster dedicated to accelerating the development of new cancer diagnostics and medicines.