McMaster University invites qualified bidders to submit responses for the supply of a Contract Research Organization (CRO) to provide clinical monitoring services, medical monitoring, and regulatory support for an academic, international 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 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.
This trial will be conducted at approximately 45 clinical sites 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.
Applicants must be able to provide regulatory and clinical site monitoring, medical monitoring and regulatory guidance for the above study. The clinical trial is focused on retinal disease, specifically Diabetic Macular Edema (DME) and preference will be given to a service provider with skills and experience within the ophthalmologic field.
The trial requires clinical monitoring services within the designated countries for the study, including Canada, the United States, the United Kingdom, and Australia. The sponsor is located in North America and will require support with regulatory applications and stronger representation in the non-North American countries (United Kingdom and Australia). The proponent must be the protocol point of contact for sites and provide study training as necessary.
The proponent will monitor site activities related to the trial including: Investigational Medicinal Product (IMP/Study Drug), IMP label compliance with regulations, local regulatory compliance, data collection verification, inventory management, accountability procedures and protocol adherence. It is expected the proponent is capable of on-site and remote monitoring. They can provide regular summary reports to the sponsor, provide internal auditing services and support the sponsor with preparation for inspections and audits.
The proponent will support the sponsor and sites with safety reporting and compliance, Serious Adverse Event (SAE) reporting, including the reporting of Suspected Unexpected Serious Adverse Reaction (SUSARs) to regulatory authorities in the applicable countries.
The proponent will provide medical monitoring in each of the countries in regard to the IMP, retinal disease, and ophthalmology.
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.
