Tender for the Central Radiological Imaging Review for the University of Birmingham

Description

The University of Birmingham invites tenders for a collaboration with a medical imaging company to complete a central review of tumour scans by blinded independent review committee (BIRC) to confirm tumour responses as part of a clinical trial. The review, related documentation and processes are required to be carried out meeting the standards required for FDA and EMA submissions, i.e. a Charter, all Supporting manuals and technical documentation and internal SOPs/processes, available for FDA audit if required. The primary objective of this analysis is to assess disease response according to the INRC guidelines (Park 2017) and to use independent assessors to maximize inclusion of patients with missing data at one or more sites or time points. The project will also identify patients whose INRC overall response is definitively not evaluable and who should be excluded from analysis. Finally, this assessment will use all available information for each patient. Expected imaging modalities include CT, MRI, MIBG and 18FDG PET/CT. This project may be funded by the European Regional Development Fund (ERDF) or; - European Structural and Investment Fund (ESIF) or; - Research Councils UK (RCUK), the strategic partnership of the UK's seven Research Councils. Please refer to Appendix A for full specification of requirements via https://in-tendhost.co.uk/universityofbirmingham/aspx/Home