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Clinical Studies In Collaboration With Industry In Helse Vest

​Joint solution for contracting clinical studies in Helse Vest

 

The hospitals in Helse Vest have a joint solution for contracting clinical studies to be carried out in collaboration with industrial partners. We have lawyers who review contracts, and advisers who prepare budgets. Since each hospital is its own legal entity, separate agreements must be entered into with each individual hospital. Our advisers ensure that differences between hospitals are taken into account in these agreements.

Section for Research and Innovation at Helse Bergen HF handles the agreements for:

  • Helse Bergen HF, Haukeland University Hospital (Bergen and surrounding area, in addition to being regional hospital)
  • Helse Fonna HF (Haugesund and surrounding area)
  • Helse Førde HF (Førde and surrounding area)
  • Helse Stavanger, Stavanger University Hospital (Stavanger and surrounding area)
  • Haraldsplass Deaconess Hospital AS (Bergen and surrounding area)

 

Submission of a new study

When one or more hospitals in the region have been selected for participation in a study, it must be submitted, preferably through the portal eStudie​.

Several hospital can be selected in the same submission. In the portal, hospitals and investigators must be reccorded, and study documents uploaded. Relevant documents are study protocols, laboratory and radiology manuals and, for example, draft agreements and budgets.

If you have any questions, please contact us on email


Most of our partners in the industry wish to use their own contract template for clinical studies. If you do not have your own template, this can be used for agreements with hospitals in Helse Vest. 

 
The rates below are listed in Norwegian kroner.
 
Hourly rates study personnel:
 

From 1.11.2023

  • Doctor: 1700
  • Study Nurse: 900
 
20 percent indirect costs (overhead) must be calculated on study visits. The rate is for all hospitals in Helse Vest.
 
Fixed costs per contract, including indirect costs (all amounts in NOK): 
1.01 National coordinator fee:​ 40 000
​​1.02 Start up fee, physicians:​ 18 000
​1.03 Start up fee, study nurses Department:​ 12 000
​1.04 Start up fee, study nurses clincal trial ward:​ 23 000
​1.05 Start up fee - laboratory:​ 5 000
​1.06 Start up fee - pathology:​ 5 000
​1.07 Start up fee - radiology:​ 7 000
​1.08 Start up fee - admin (R&D): ​6 000
​1.10 End of study fee -department: ​5 000
​1.11 End of study fee - clincal trial ward: ​6 000
​1.12 End of study fee - admin (R&D):​ 2 000
​1.13 Archiving / records retention 25 yrs:​ 10 000
​​​
2.01 Conditional: Per protocol amendment requiring implementation/training site:​ 10 000
​2.02 Conditional: Per contract amendment:​ 3 000
​2.03 Conditional: Per change of CRA > once per 12 months: ​3 000​
​2.04 Conditional: Investigator meeting participation, per participant per day: ​6 000
​2.05 Conditional: Audit fee, per day:​ 10 000
​2.06 Conditional: Subject re-consent, per patient per consent: 1 020
​2.07 Conditional: Recruitment fee:​ 1 020
​2.08 Conditional: Per SAE case (if not included in visit fee): ​6 000
Costs for use of laboratories, radiology etc. must be calculated for each individual study and may vary somewhat between hospitals. 
 


The individual hospital will invoice according to the agreement entered into. For agreements with Norwegian contracting parties, 25 % VAT will be added. 
​


If you wish to use pharmacy services for import or other drug handling in your studies, you must enter into an agreement with Sjukehusapoteka Vest HF. Sjukehusaapoteka Vest can be contacted at: 

Stavanger: KLUT-SiS@sav.no​ 


Helse Vest has a patient population of approx. 1.1 million and covers all therapy areas. See table for the therapy area for clinical studies in each hospital. 


There are two NorTrials centers in Helse Vest: Brain health and Autoimmune diseases and inflammation. Read more about the NorTrials initiative. 
​
Information about clinical studies at hospitals in Norway is available on the hospitals' websites and on Helsenorge. 


Last updated 2/13/2023