We provide grant and budget reviews for investigator teams to ensure necessary financial support is requested to support research conduct.

We offer a range of consultation services tailored to pediatric rare disease clinical trials in Canada.  

We connect study teams with clinical and methodological experts—both nationally and internationally. 

We assist in the development of clinical trial protocols, including the transition of funded grant applications into Health Canada-preferred protocols.  

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. 

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

We have a dedicated monitoring team to perform risk-based remote and on-site monitoring to meet the Health Canada required sponsor obligations.  

We facilitate a centralized data safety monitoring board to ensure participant safety and provide expertise on clinical trial conduct for continuation, modification, or termination.  

We offer 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.  

We provide high-level study management as a stopgap while grant or site resources are mobilizing, as well as comprehensive project management services tailored to pediatric rare disease clinical trials, ensuring efficient coordination, oversight, and successful execution from inception to completion. 

Benefit from expert assistance in navigating and facilitating the contracts and agreements process crucial for pediatric rare disease clinical trials, leveraging ongoing contract streamlining initiatives championed in Canada for seamless collaboration and efficiency.  

We provide specialized biostatistical and simulation modelling services tailored to pediatric rare disease clinical trials, ensuring robust study design and accurate data analysis to support evidence-based decision-making and successful trial outcomes within the network.  

We provide tools and resources to facilitate knowledge translation for your studies, including infographics and lay summaries for patients, families, and healthcare providers. 

Collaborate with patient and family partners to ensure inclusivity and relevance in study materials, including protocols, consent forms, recruitment materials, and more, fostering a patient-centred approach. 

We facilitate equity, inclusivity, and diversity in clinical trials by offering language, cultural, and translation services to enable broader and more inclusive participation in rare disease clinical trials. 

Our dedicated team facilitates the identification and selection of qualified investigators and sites.