About us

Annual summary of publications

Source: Publika.no

Staff

6 physicians, 40 study nurses, 9 site project managers, 5 medical quality registrar 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

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

Pharmaceutical Industry
Authorized by Novartis – Part of Oncology Translational Medicine (OTM) network
Selected partner, 1 og 6 European BMS Immune-Oncology Centers of Excellence
MD anderson Cancer Center (part of the Global Academic Program)
EORTC Network of Core Institutions (NOCI) for translational research
ESMO European Society for Medical Oncology
Nordic Network for Early Cancer Trial (Nordic-NECT)
Member of Nordic Trial Alliance
“In house developed-trials” in collaboration with Institute for Cancer Research:

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