McMaster University invites qualified bidders to submit responses for the supply of a Clinical Trial Management System (CTMS) that includes an integrated Electronic Data Capture (EDC) with electronic Case Report Forms (eCRF) and electronic Trial Master File (eTMF) 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.
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.
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.
The sponsor of this academic research project requires a platform that will be used as a tool for clinical trial management, randomization and data collection on an investigator-initiated study with an approved IMP for a new indication. The project will be approved and monitored via the various international regulatory authorities in Canada, USA, United Kingdom, and Australia. The proponent platform must be regulatory compliant with the various regulatory authorities and current GCP practice.
The sponsor is seeking applications from proponents to provide a Clinical Trial Management System (CTMS) that integrates an Electronic Data Capture (EDC) system with electronic case report forms (eCRF) required for the trial. The integrated platform will aid with collection, management and tracking of the site level and sponsor level electronic Trial Master File (eTMF). The system will aid with communication, reporting, study progress, tracking, identification of irregularities, integrate the eTMF and eCRF systems. The system(s) must allow for communications and data monitoring for the site, sponsor and clinical trial monitors. The EDC will be used by the sites for randomization, data collection and communications. The system must provide a secure channel for data output and an audit trail that is both regulatory compliant and audit/inspection-ready.
The proponent will need to setup, train sponsor staff on CTMS, EDC and eTMF systems and provide technical support throughout the study.
