Consultation & Design Phase
Companies with prioritized technologies are invited to continue to the Consultation & Design phase* in which they are paired with a methodological centre (MC) that will develop an evaluation proposal specific to the needs of the technology. This is an iterative process with ongoing communication between the methodological centre, the company and EXCITE.
During this process, clinicians and scientists may be consulted to provide their expertise (all confidential information is protected under a non-disclosure agreement). The methodological centre may also recruit investigators at participating centres to help in the proposal development.
Proposals are designed to address:
- Regulators’ needs (safety and efficacy) in Canada and elsewhere (if requested)
- Additional health system requirements (clinical utility, comparable effectiveness through systematic review and economic analysis)
- Matters relevant to the expedited adoption of the technology following licensing
If requested by the technology innovator, proposals may include added offerings to investigate and mitigate specific potential barriers to market penetration.
Once the company is satisfied with the proposal design and high-level budget, the proposal is circulated for EXCITE stakeholder input.
An HTA review committee reviews each proposal to ensure that it addresses the needs of the health system, such that the resulting data would be sufficient for a reimbursement review. Health Canada and other regulatory authorities, as appropriate, will also be consulted. The EXCITE Management Board reviews the proposal and high level budget for approval.
If approved, EXCITE submits the proposal to the company for acceptance of:
- A final iteration of the proposal
- A budget describing the cost of the evaluations (within reasonable variance)
- A timeline of milestones/disbursements
Once the company accepts and signs off on the above, the MC expands the proposal into a full protocol and finalizes the evaluation budget**. The technology is now ready to move to the next phase: Evaluation.
TIMING: The Consultation & Design process takes roughly 30 to 36 weeks.
*Should a company elect to continue in the EXCITE program, a Master Participation Agreement will be signed between MaRS and Company. As well, Company will sign a Services Agreement with the MC to outline the proposal and protocol deliverables and associated costs. Note: the proposal development fee is $25,000 for an SME headquartered in Ontario and $30,000 for all other companies. The protocol development fee is $30,000 for all companies (all figures CAD). ** Note that evaluation budgets will include an EXCITE Program Management Fee applicable to all amounts except institutional overhead: 10% for SMEs headquartered in Ontario; 15% for all other SMEs; 20% for MNEs.