Clinical Validation Program (YORKbiotech)

CLOSED - Call For Letters of Intent from SMEs.  To apply to this program, please review the following guidelines. 

OVERVIEW

A pilot PROGRAM for clinical trials (testing) of Ontario innovative products in the field of Medical and Assistive Technologies (MAT), with priority to assist SME and relevant technology developers, has been established in a collaborative venture among YORKbiotech and htx.ca - The Health Technology Exchange (HTX). Letters of Intent (LOIs) are invited from suitably qualified organizations that wish to be considered for support via this PROGRAM. The PROGRAM is restricted to devices that are not likely to require significant regulatory approval (i.e., Class 1 devices). The available pool of funds for this pilot project is up to $200,000. It is anticipated that several products will be supported from the available pool of funds. Successful applicants will be expected to match the amount of any grant made available to them.

LOIs will be evaluated based on information relating to the product to be validated including its innovation (intellectual property protection), market niche, anticipated market impact, its likely patient impact, and suggestions regarding the protocol of the proposed trial or testing. The evaluation committee will be comprised of representative members of YORKbiotech and HTX, and experts in the field of interest. Those who are successful in this first round of adjudication will be invited to meet with the representatives of HTX and YORKbiotech to discuss details of a possible clinical trial to be conducted with expertise from the appropriate YORKbiotech Members.

An estimate of the costs of each specific trial will be developed collaboratively with the company. Day to day running costs will be drawn from the funds contributed to the Project budget by YORKbiotech and the SME. Indirect (overhead) costs and certain costs possibly incurred on advice from committed, directly-involved expert academic investigators will be identified and included in the Project budget that forms part of the formal Funding Agreement administered by YORKbiotech.

It should be recognized that the credentials of the participants conducting the trials would serve as a strong selling point for products that meet the rigours of the protocols developed. The participants involved would take responsibility for the mandatory ethical aspects and related requirements of the institutional Research Ethics Board. Following on the clinical trial, it is expected that in addition to a report detailing the protocol and the results, a publication would be prepared for submission to a peer-reviewed journal pertinent to the domain of application of the product.

ELIGIBILITY

LOIs should be submitted electronically to the YORKbiotech office at maryanne@yorkbiotech.ca.

AWARD NOTIFICATION

Notification letters will be sent ordinarily within 4 weeks of the deadline for submissions to all applicants following final decisions. Letters to successful project leaders will provide instructions on how to proceed with the establishment of the project.

For Additional Information

The complete application form is available on the YORKbiotech www.yorkbiotech.ca and HTX www.htx.ca websites. For more information:

Click here to download the application template