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Clinical Research Centre

Research infrastructure The Clinical Research Center is a joint resource for Region and University for near-patient clinical studies. The Clinical Research Center may provide support to researchers from an idea to a completed study: anything from research facilities, equipment and GCP (Good Clinical Practice)-trained nurses to regulatory and administrative support in planning of a new clinical trial, management and end reports. At the Center both academic and corporate-sponsored studies are conducted.

The Clinical Research Center (KFC-swedish acronym) wants to simplify for researchers and companies to conduct clinical research in Västerbotten. Our employees have a great deal of experience and are there to assist you from idea to completed study. As a researcher you choose for yourself how much support you want in your study, you can come to KFC only for an advisory meeting or (if possible) get your entire study done with the help of our GCP-trained research nurses and study coordinators. KFC is located at the University Hospital of Umeå, where both academic and company-sponsored studies are conducted. The premises are open to researchers from all regional operations and university units engaged in patient-related, clinical research.

The use of premises, laboratories and simpler equipment is free of charge for academic (non-corporate sponsored) research that has applied for and obtained a place. The use of more complicated equipment requiring human resources is charged. For clinical study support, a first counseling visit is free of charge.

Resources at the Clinical Research Center includes:

  • Research nurses with long experience, educated in Good Clinical Practice
  • Laboratory for handling blood samples and possibilities to short term storage
  • Research facilities and equipment such as ECG, ultrasound, DXA, RMR etc

Additional support includes:

  • Regulatory and administrative support in planning of a new clinical trial
  • Writing and review of Clinical Trial Protocols
  • Designing Case Report Form (CRF) printed or electronic form (eCRF)
  • Applications to Medical Products Agency and Ethics Committee
  • Biobank applications
  • Designing patient information/informed consent forms
  • Project management
  • Reviewing contracts
  • Cost estimation and negotiation
  • Monitoring
  • Randomization
  • SAE and SUSAR reporting
  • Medical writing
  • Producing study documentation
  • GCP education
  • Contacts with experts in clinical studies (such as statistics, epidemiology, health economics)
  • Contact with regional resources (such as research units, quality register centers, biobanks, cancer centers).

The Clinical Research Centre arranges regular training in Good Clinical Practice both on basic and advanced level as well as for managers in the health care system. See information on upcoming courses at https://regionvasterbotten.se/forskning/stod-till-forskning/kliniskt-forskningscentrum/utbildningar (in Swedish).

Via the regional collaboration Kliniska Studier Sverige - Forum Norr  there are clinical research centres available in all four regions in the northern region. This enables researchers to conduct studies in the entire northern health care region of Sweden and thus give citizens a more equal opportunity to partake in studies. Forum Norr also takes part in a number of  national and regional development initiatives to improve clinical studies both on the national and regional arena. Read more on the collaboration Forum Norr and contact to other Clinical Research Centres at www.forumnorr.se.

Contact

klinisktforskningscentrum@regionvasterbotten.se