For Investigators

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RareKids-CAN offer a range of services and support for pediatric rare disease clinical trials for Investigators in Canada. Eligible projects must meet the following criteria:

For all pediatric rare disease clinical trials

We offer a range of consultation services tailored to pediatric rare disease clinical trials in Canada. Leverage from our in kind consultations with experts in methods and design, pharmacology, biostatistics, knowledge mobilization, and regulatory affairs to support your protocol development and grant application.

For Advanced Therapy Medicinal Product trials

We offer project-specific electronic case report form (e-CRF) development in a validated REDCap database housed at the Women and Children’s Health Research Institute.

For all pediatric rare disease clinical trials

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.

For Advanced Therapy Medicinal Product trials

As well as providing database development, we also offer database management in a validated REDCap database housed at the Women and Children’s Health Research Institute.

  1. Interventional clinical trial

  2. Intervention impacting a pediatric population (or, in the case of pregnancy, the fetus rather than the mother)

  3. Includes conditions with an Orpha code on Orpha.Net or has a prevalence of less than 1 in 2,000

  4. Exclusion of oncology clinical trials

For projects outside of this scope, please submit your project request to MICYRN.

Our services and support includes:

Request a consultation:

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For all pediatric rare disease clinical trials

We facilitate streamlined ethics submissions for multi-jurisdictional clinical trials.

For all pediatric rare disease clinical trials

We offer to support to project teams looking to develop longitudinal registries with one or more of the following objectives: 

  •  Enhance trial readiness by identifying participants for therapies in development

  • Serve as a source of external control data for single-arm clinical trials

  • Enable registry-based clinical trials

  • Support post-trial real-world evidence generation for Health Technology Assessment (HTA) purposes