NMD4C

RareKids-CAN offers a range of subsidized services for investigator-initiated (academic-led) pediatric rare disease clinical trials. The goal of these services is to stretch project funds further, ensuring greater impact and cost savings. Below is the list of subsidized services offered:

100% Subsidized Services (RareKids-CAN will cover 100% of the cost of the following services):

• • Consultations: We will conduct a robust consultation to identify areas of needs for your project with valuable involvement from relevant sub platforms based on your project needs to ensure your project receives adequate support.
  • High-level project management: An experienced project manager will ensure efficient coordination, oversight, and successful execution from inception to completion for your clinical trial.
  • Database build (not including management): We will provide project-specific electronic case report form (e-CRF) development and database management in a validated REDCap database housed at the Women and Children’s Health Research Institute (WCHRI).
  • Data Safety Monitoring Board: From our repository of individuals with specific expertise relevant to your project, we facilitate a centralized data safety monitoring board to ensure participant safety and provide expertise on clinical trial conduct for continuation, modification, or termination.

50% Subsidized Services (RareKids-CAN will cover 50% of the total cost of the following services):

• • Regulatory submissions: We assist study teams in the preparation and submission of clinical trial applications, investigational testing authorizations, and single-patient study applications for regulated clinical trials to Health Canada. We will also assist in adverse event reporting.
  • Monitoring: We have a dedicated and experienced monitoring team to perform risk-based remote and on-site monitoring to meet the Health Canada required sponsor obligations.

All other services are 100% cost recovered (i.e., RareKids-CAN will not subsidize)

If you have a clinical trial that require these services or would like to further discuss, you can complete the project intake form.