NorTrials Coordinating Unit
The NorTrials Coordinating Unit is responsible for overseeing the progress and activities of the NorTrials initiative in close collaboration with the organization and key partners.
Function
The unit serves as a national hub to strengthen collaboration between the healthcare industry and Norway’s specialist health services to facilitate clinical trials across the country. Its goals include creating a professional system for handling and forwarding trial inquiries, offering efficient and simple solutions for industry partners wishing to collaborate with Norwegian hospitals.
Tasks for Industry Partners
- National entry point: NorTrials Feasibility Portal
- Quality assurance of patient information and consent forms
- International promotion
Services for Specialist Health Services
- Advisory services
- Knowledge sharing and competence building
NorTrials Feasibility Portal
The NorTrials initiative offers “one point of entry” for pharmaceutical and medical device companies looking to collaborate with Norwegian research environments.
Quality Assurance of Patient Information and Consent Forms
The Coordinating Unit provides a free service to assist industry sponsors in reviewing and ensuring the quality of patient information forms before submission to regulatory authorities. This service includes general proofreading and compliance checks against the templates of the Regional Committees for Medical and Health Research Ethics (REK), adhering to ICH-GCP and national SOP guidelines. Sponsors must submit both the original (if in a language other than Norwegian) and a Norwegian draft. The estimated review time is up to five business days.
Read more about the patient information quality service here.
International Promotion
In partnership with Innovation Norway, NorTrials facilitates international arenas where healthcare companies and Norwegian researchers can connect and plan future projects.
NorTrials Advisor Services
NorTrials offers advisory support to hospitals with limited research support, providing practical assistance for trial feasibility, planning, and launching of clinical trials. The unit’s advisors have extensive experience across all phases of clinical trials and can assist healthcare institutions with:
- Feasibility: Guidance on confidentiality agreements (CDAs) and sponsor questionnaires.
- Planning: Staff training, resource planning, internal alignment, and privacy guidance.
- Start-up and execution: Support with study procedures, document management, and monitoring preparation.
Knowledge Sharing and Competence Building
There is a need for greater awareness of clinical trials among the general population and healthcare professionals. The Coordinating Unit contributes by disseminating knowledge through its website, social media, informational materials, and by hosting digital or in-person events upon request. In collaboration with NorCRIN, the unit also facilitates training courses to enhance competence in clinical trials.
About us
The coordinating unit consist of head of unit, Signe Øien Fretland (100%), coordinator, Ellen Johnsen (20%), two reserach advisors; Ingrid Fjeldheim Bånerud (40%) and Anne Marie Halstensen (40%), and one communication advisor, Eline Feiring (20%).
Contact
Email: contactnortrials@ous-hf.no