McMaster University invites qualified bidders to submit responses for the supply of Imaging Services for Ophthalmology for use in an academic, multi-national clinical trial in accordance with the terms of this Request for Proposals.
Bidders must quote the entire bid. Partial bids will not be accepted.
This trial will be conducted at approximately 45 clinical sites total in Canada, the United States, the United Kingdom, and Australia. It is sponsored and conducted by McMaster University, Centre for Evidence-Based Orthopaedics (CEO) in the Department of Surgery. The trial is a multi-centre randomized controlled trial (RCT) of approximately 400-450 participants with a confirmed diagnosis of diabetes mellitus and a diagnosis of macular edema secondary to diabetic retinopathy. Eligible and consenting participants will be randomized to one of two treatment groups: 1) the T&E (intervention arm) or 2) fixed dosing (control arm). Participants on the trial will receive treatment for Diabetic Macular Edema (DME) with faricimab and randomized to one of the two arms of the study. Participants will be on the study from baseline to approximately week 100 and we anticipate the full trial will take 4 years.
The sponsor of this trial requires an imaging platform that can collect, QC and export DICOM images to reading centre, store and backup, ophthalmologic images from approximately 45 sites across Canada, USA, UK and Australia to the study sponsor. The imaging services include:
- An Imaging platform regulatory compliant with current country regulatory agency standards, GCP, HIPAA and 21 CFR part 11 compliant, to transport ophthalmology images from the sites to the sponsor reading centre.
- Site support services that includes technical support, training for readers and research site staff, BVCA certification, initiation of site in relation to the imaging component.
- General imaging support services including reporting to sponsor, monitoring of quality and accuracy of images entering the system, status reporting to sponsor.This is an academic, investigator-initiated study sponsored by McMaster University. Hoffman La-Roche is providing study drug faricimab, as well as funding for activities on the trial. Results of the trial will be submitted for publication and will also be used by the drug provider for regulatory filing.
For this project the following technologies will be captured:
- Spectral domain – optical coherence tomography (SD-OCT)
- Optical coherence tomography angiography (OCT-A)
- Ultra wide – colour fundus photography (UW-CFP)
- Ultra wide – fundus autofluorescence (UW-FAF)
- Ultra wide - fluorescein angiography (UW-FA)
Note: There are confidential documents attached to this opportunity. A Non-diclosure Agreement must be signed for the documents to be released to interested bidders.
