After a project or clinical trial has successfully undergone CUOG Expedited Review, a corporate agreement is reached between CUOG and the sponsor to move forward with the project or clinical trial. CUOG then executes a performance based corporate agreement with the sponsor.
There are 3 basic components to this agreement:
1. Project Management Fee:
A flat rate project management fee to cover the administrative costs incurred throughout the duration of the project or study.
2. Performance Based Accrual (PBA) Charge:
In addition to the project management fee, the Sponsor is required to pay CUOG a specified amount for every patient entering the project or clinical trial across all CUOG participating sites. The full cash value of the agreement is calculated by multiplying the number of subjects enrolled in a given study by a percentage of the per-case funding. An estimate of the PBA charge is pre-determined between the Sponsor and the Consortium, and adjusted accordingly over the progression of the study. Alternatively, CUOG will determine an incremental fee for service based on enrollment milestones achieved throughout the duration of the study.
3. Request for Unrestricted Grant
*[pricing is subject to change without notice]
CUOG directs revenues generated from Sponsor Agreements to fund the collective academic, research, corporate and administrative objectives of the Consortium. In return CUOG offers the following value-added services which are of shared benefit to the uro-oncology community, pharmaceutical industry both locally and abroad:
- Expedited review of clinical trials and projects
- Clinical practice guidelines
- Protocol development
- Patient registries surveys
- Project / clinical trial feasibility assessments
- Site selection
- Centralized negotiations and study budgets
- Fast track communications
- Manuscript / abstract preparation
- Representation on Steering Committees, Advisory Boards,
- Regulatory applications / Assignment of Senior Medical Officers (SMO’s)