Support for Your Clinical Study
We support all stages of clinical studies and tailor our services to your needs. We assist with study conduct, sample handling, data processing, and regulatory applications, and can also contribute to additional tasks. Please contact us to learn more about how we can support your study.
Our Contribution to Clinical Studies
The staff at FHU consist of experienced professionals, study coordinators, and healthcare personnel who actively contribute to the conduct of clinical studies from planning to completion. They perform practical tasks related to participant contact and study follow-up, including participant recruitment, conducting examinations, and sample collection. They are also responsible for the processing and storage of biological materials in accordance with applicable procedures and quality standards.
FHU staff also provide administrative and technical support, including coordination of study operations, use of digital solutions for data collection, and quality assurance of data and documentation. They are proficient in the use of medical-technical equipment and ensure the accurate execution of measurements and examinations.
In addition, FHU can assist with the preparation of study protocols, the development and submission of applications to REK and CTIS, as well as the registration of UiB studies on ClinicalTrials.gov.
The staff also contribute to ensuring that studies are conducted in accordance with applicable guidelines and standards, and can support researchers with practical, logistical, and methodological aspects throughout the course of the study.
Infrastructure
We offer excellent facilities designed for the conduct of clinical studies, including:
- Laboratory for handling and processing of samples
- Spacious and flexible examination rooms equipped with a workstation, examination couch, and equipment for height and weight measurements
- Multiple sampling stations for collection of biological material (e.g. blood, saliva, and microbiota)
- Metabolic kitchen for preparation and handling of test meals
- Utility room with decontaminator and autoclave
- Storage facilities for study materials
- Ultra-low temperature freezers for temporary storage of biological samples
- Meeting rooms with audiovisual equipment
In addition, we have a well-established collaboration with Biobank Haukeland, as well as workstations with network access to the University of Bergen and Haukeland University Hospital.
Medical technical equipment
- Spirometer
- ECG
- Blood pressure monitors
- Bioimpedance equipment for body composition analysis
- BodPod gold standard for body composition measurement
- Equipment for anthropometric measurements
- Ambient and refrigerated centrifuges
- Dynamometer (handgrip strength)
- Defibrillator
e-Infrastructure
Projects conducted at FHU may make use of our EasyTrial license. EasyTrial is a combined booking and data collection system that ensures secure collection and processing of data for both decentralized and clinical studies. EasyTrial.net is a web-based system, providing access to study data at any time and from any location. EasyTrial.net is GDPR compliant, and you retain full control over your data.
The Clinical Trial Management System (CTMS) includes:
- Electronic data capture – eCRF, with full flexibility for the creation and management of eCRFs
- Electronic surveys/questionnaires for direct data collection into the database
- Study overview, including data collection status
- Appointment scheduling, resource management, and planning system
- Automatic email and SMS reminders
- Digital informed consent via Posten’s e-signature solution
- Tools for participant randomization
- Easy import of clinical test results
- Recording of medication use
- Recording of adverse events (AE) and serious adverse events (SAE)
- Document database
- Support for multicentre studies
- Secure access control
- Export of data to tabular formats (Excel, SPSS, etc.)
Quality Assurance
RUHS/FHU has established standard operating procedures (SOPs) for all study-related activities conducted at the unit. We adhere to the ICH Good Clinical Practice E6 (R3) guidelines, and our staff regularly update their competencies, including mandatory GCP training every two years.
We ensure quality assurance of study documentation in accordance with current NorCRIN guidelines. We also have expertise in the shipment of biological materials on dry ice in compliance with applicable IATA regulations. In addition, we provide training in the proper use of EasyTrial, perform risk and vulnerability assessments (ROS analyses) of our systems, and ensure sound data management in line with current requirements and standards.
Medical technical equipment is maintained and calibrated in accordance with the manufacturer’s recommendations.
Research Projects Conducted at RUHS/FHU
RUHS/FHU supports research groups across a wide range of disciplines. We have conducted studies with participation ranging from 3 to over 3,000 individuals, aged 6 to over 80 years. We perform various study types, including observational studies, interventional trials (phase III and IV), and population-based studies
Cardivascular research
FATCOR Follow-up Study
PI: Helga Bergljot Midtbø | Period: 2022-2024 | Affiliation: Helse Bergen
Study on the prevalence of cardiovascular disease in individuals with obesity
IDA Study
PI: Eva Gerdts | Period: 2020-2022 | Affiliation: Helse Bergen
Personalized blood pressure treatment
HUSK3
PI: Eva Gerdts | Period: 2018-2020 | Affiliation: UiB/Helse Bergen
Hordaland Health Study. See website here
JOINTHEART
PI: Helga Bergljot Midtbø | Period: 2020-2021 | Affiliation: Helse Bergen
Study on rheumatoid arthritis and cardiovascular disease
Lung Health
BORALIS
PI: Randi J. Bertelsen | Period: 2021-2024 | Affiliation: UiB
Study on whether treatment of periodontitis may influence lung health
RHINESA 4G
PI: Cecilie Svanes | Period: 2018-2021 | Affiliation: Helse Bergen
Generational study on lung health. See website
COVID-19 RHINESA
Ir: Cecilie Svanes | Period: 2020-2021 | Affiliation: Helse Bergen
Susceptibility to COVID-19 and third-generation follow-up
EPHOR
PI: Cecilie Svanes | Period: 2022-2023 | Affiliation: UiB
Occupational exposure and its impact on lung function
ECRHS 4
PI: Randi J. Bertelsen | Period: 2022-2023 | Affiliation: Helse Bergen
Fourth round of the lung health survey
Nutrition
FOOD SUPPLY
PI: Zoya Sabir | Period: 2025-dd | Affiliation: UiB
Diet and nutritional status among community-dwelling older adults
THE MILK STUDY
PI: Hanne Rosendahl-Riise | Period: 2024-2024 | Affiliation: UiB
Plant-based alternatives: iodine status and lipid profile
THE MACROALGAE STUDY
PI: Inger Aakre | Period: 2022-2022 | Affiliation: UiB/Institute of Marine Research
Iodine and heavy metal content in seaweed products
THE BREAD STUDY
PI: Jutta Dierkes | Period: 2019-2020 | Affiliation: UiB
Effect of fibre-rich bread on postprandial glucose levels
THE BREAD STUDY 2
PI: Jutta Dierkes | Period: 2025-2026 | Affiliation: UiB
Types of bread and their impact on blood glucose and satiety
CARBHEALTH GASTRIC EMPTYING
PI: Hanne Rosendahl-Riise | Period: 2020-2020 | Affiliation: UiB
Effect of fibre-rich bread on gastric emptying and postprandial glucose levels
THE FASTING STUDY
PI: Vegard Lysne | Period: 2021-2021 | Affiliation: UiB
Investigation of metabolic changes over 24 hours following a meal
THE IODINE STUDY
PI: Hanne Rosendahl-Riise | Period: 2021-2021 | Affiliation: Institute of Marine Research/UiB
Validation of the iodine calculator
CARBFUNC
PI: Simon Dankel | Period: 2017-2020 | Affiliation: UiB
Dietary intervention study.
CARBHEALTH
PI: Jutta Dierkes | Period: 2021-2023 | Affiliation: UiB
Effect of fibre-rich bread on gastric emptying and postprandial glucose levels
NUTRITIONAL KNOWLEDGE AMONG YOUNG WOMEN
PI: Lisbeth Dahl | Period: 2024-2025 | Affiliation: Institute of Marine Research
Effect of nutrition education in young women
MORMIK
PI: Jutta Dierkes | Period: 2024-2025 | Affiliation: UiB
Maternal diet and fetal exposure to microplastics
Dietary Supplements
ENEDRIA
PI: Bernt Lindtjørn | Period: 2026-dd | Affiliation: UiB
Health effects of fish and algae-derived dietary supplements
CPH
PI: Rolf K. Berge | Period: 2021-2021 | Affiliation: UiB
The effect of chicken protein supplementation on abdominal obesity.
FHF
PI: Rolf K. Berge | Period: 2021-2021 | Affiliation: UiB
The effect of marine protein on cardiovascular risk
PSORAX35
PI: Kåre Steinar Tveit | Period: 2017-2019 | Affiliation: UiB/Arctic Nutrition
The effect of herring roe on psoriasis
Psychiatry
PRO-DIALOG
PI: Ingvar Bjelland | Period: 2021-dd | Affiliation: Helse Bergen
A dialogue-based method for the early identification of developmental challenges in children
ENACT
PI: Maj-Britt Posserud | Period: 2021-dd | Affiliation: Helse Bergen
Parental guidance program for parents of children with autism spectrum disorders
DIALECTICAL BEHAVIOR THEARPY
PI: Gro Janne Wergeland | Period: 2022-2023 | Affiliation: Helse Bergen
Clinical quality registry
ANXIETY INTERVENTION
PI: Bente S. M. Haugland | Period: 2023-2024 | Affiliation: UiB
Cancer
ROSALIND
PI: Bjørn Tore Gjertsen | Period: 2025-dd | Affiliation: Helse Bergen/CURE51
Exceptional cancer survival and underlying factors
LIVER-R
PI: Inger Marie Løes | Period: 2026-dd | Affiliation: Helse Bergen/Astra Zeneca
Treatment response and survival in liver and biliary tract cancer
PREPAIRD
PI: Eli Marie Grindedal | Period: 2024-dd | Affiliation: Oslo University Hospital
Early diagnosis of pancreatic cancer and hereditary risk
Pharmaceutical trials
MT-7117-A-301
PI: Aasne Karine Aarsand | Period: 2022-dd | Affiliation: Helse Bergen/MTDA inc
The effect of a novel drug on erythropoietic protoporphyria (EPP)
MITSUBISHI i MT-7117-G01
PI: Aasne Karine Aarsand | Period: 2021-2022 | Affiliation: Helse Bergen/MTDA inc
Clinical drug trial for erythropoietic protoporphyria (EPP)
APOLLO
PI: Aasne Karine Aarsand | Period: 2026-2026 | Affiliation: Helse Bergen/Disc Medicine
Study of bitopertin in EPP and XLP
Infection
COVID-19 INFECTION
PI: Rebecca Cox | Period: 2020-2022 | Affiliation: UiB
Clinical and immunological responses to COVID-19 infection.
PANORAMIC NORWAY
PI: Nina Langeland | Period: 2023-2024 | Affiliation: Helse Bergen
The effect of Paxlovid on persistent COVID-19 symptoms
Diagnosis
PORT-77
PI: Aasne Karine Aarsand | Period: 2026-dd | Affiliation: Helse Bergen/Portal Therapeutics
New treatment for photosensitive porphyria (EPP)
TINNITOX
PI: Karen Herlofson | Period: 2024-dd | Affiliation: Sørlandsklinikken
Botulinum toxin A (BoNTA) treatment for tinnitus associated with bruxism and jaw pain
LIPØDEM
PI: Hildur Skuladottir | Period: 2022-dd | Affiliation: Haraldsplass Diakoness Hospital
Sub-study within the national LIPØDEM study
PREDPOR
PI: Aasne Karine Aarsand | Period: 2020-2023 | Affiliation: Helse Bergen
Disease activity and long-term complications in porphyria
POLYMYALGIA RHEUMATICA IN PRIMARY CARE
PI: Lene Kristin Brekke | Period: 2026-dd | Affiliation: Haugesund Sanitetsforenings Revmatismesykehus
Diagnostics, treatment, and long-term outcomes
DIAKOST
PI: Simon Dankel | Period: 2021-dd | Affiliation: UiB
The effect of two different diets on remission of type 2 diabetes
PANGUT
PI: Eirik Søfteland | Period: 2019-2022 | Affiliation: Helse Bergen
Case study on the incretin effect
Other projects
RE:STATE
PI: Karsten Specht | Period: 2021-2023 | Affiliation: UiB
Reliability of neuroimaging data and influencing factors