Om oss

Annual summary of publications 

Source: Publika.no

Staff

6 physicians, 30 – 40 study nurses, 11 site project managers and 1 secretary.

  • Certified, trained and working according to GCP. Updated GCP training/course every second year
  • Trained in emergency situations (physicians and study nurses) and in the management of safety events (e.g. immune-related)
  • Experienced in web based electronic data capture and easy access to a computer with web/internet high speed access
  • Resources to complete data entry and resolve queries 1- 5 working days after visit completion
  • Availability of workspace for Monitors to perform regular site visit activities including ability to access the electronic data capture website
  • Experienced in using RECIST 1.1 and irRC to evaluate tumour response

 Facilities

  • Facilities for close patient surveillance, including equipment for continuous cardiac monitoring covering seven days a week with facilities for overnight stay (co-operation with in-patient ward)
  • Close co-operation with Intensive Care Unit and 24-hour access to the hospital Emergency Response Team
  • 24-hour facilities for standard blood sample analysis with expedited processing
  • Dedicated beds, available treatment chairs and outpatient consulting rooms
  • A laboratory which includes a (blood) sample preparation area containing equipment for processing and storage of study samples in compliance with GLP and GCP
  • Staff trained to collect, process and ship samples, completing tracking logs on an ongoing basis
  • -20° C and -80° C freezers available with adequate space for the storage of study samples

 Pharmacy

  • Trained Pharmacists working according to GMP
  • Specialised in oncology
  • Dedicated to clinical trials

 Quality

  • Inspected by Norwegian Health Authority Inspectors in January 2009 and May 2019 without critical findings
  • Site specific SOPs continuously revised
  • Oslo University Hospital has one of the largest Radiotherapy departments in Northern Europe with 17 Linac’s

 Collaboration

 Tumor biopsy collection

  • Ability to collect sequential biopsies at required time-points with an established process for taking tumor biopsies from either deep or superficial lesions
  • Ability to process the samples immediately (formalin, transfer medium, snap frozen), fixation
  • Biobank for various tumor types

 Molecular and biochemical analyses

  • Routine laboratory assessments including biomarkers
  • Immunohistochemistry and immunological assays
  • Receptor expression and functional receptor analyses
  • Protein analyses (ELISA, RIA and immunohistochemical investigations)
  • MicroRNA gene analyses
  • Gene profiling with individually designed panels dependent of target and pathway

 PET and NMR (functional) imaging

  • Senior technicians and radiologist dedicated to the clinical studies
  • Access to PET-CT scanners
  • Access to MRI and CT scanner with slice CT scans, dynamic CT, ultrasound Doppler with colour contrast enhancement and a variety of other interventional diagnostic radiology and clinical physiological assessments.

 Point of excellence

  • Biobank for differenct types of cancer
  • Clinical studies with translational research as an important part
  • Immunotoxins
  • Superantigens
  • Dendritic cell vaccination
  • Telomerase vaccination
  • Cytotoxic peptide injection
  • Micrometastases
  • Immunotherapies
  • GMP Certified laboratory for preparation of therapeutic cellular products and evaluations/monitoring of immune responses
  • Production of both T-cells and DCs (including mRNA transfection) for clinical use

 Approval process

  • External review board: Last ten protocols NOMA 53 days, EC 53 days
  • Internal All protocols will be presented at the Department of Oncology Internal Review Board
  • All contracts with industry are handled by Inven2 (Tech Transfer Office)

Patient population

  • The Norwegian population: 5.3 million
  • Number of new cancer cases 2019: 34 979
  • Insidence Registry and Cancer statistics from The Cancer Registry of Norway