Facilitate identifying qualified sites and investigators nationally for participation in studies.

Study protocol development, including the transition of a funded grant application into a Health Canada preferred protocol.

Assistance in navigating and facilitating the contracts and agreements process crucial for pediatric clinical trials, leveraging ongoing contract streamlining initiatives championed in Canada for seamless collaboration and efficiency.

Consultation and support to prepare and submit Clinical Trial Applications (CTAs), Investigational Testing Authorizations (ITAs),and single-patient study applications to Health Canada for regulated clinical trials. This support includes ongoing amendments/notifications, and other correspondence as applicable.

Consultation and assistance to facilitate and streamline research ethics approval across multiple jurisdictions for multi-centre trials. Via MICYRN’s project management services and/or in collaboration with the Canadian Collaboration for Child Health: Efficiency and Excellence in the Ethics Review of Research (CHEER) initiative.

Develop (or implement external) clinical trial Monitoring Plans and provide dedicated clinical trial monitoring personnel to perform risk-based monitoring for regulated trials, adhering to Health Canada and sponsor requirements. MICYRN’s Quality Assurance (QA) Lead supports MICYRN and its members to develop QA strategies, ensuring high quality standards and audit/inspection readiness throughout the clinical trial lifecycle.

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

Database creation, management, and support in a validated REDCap web-based application and assist study teams to develop case report forms.

Study management to bridge gaps while grant or site resources are mobilizing or, if required, comprehensive project management to liaise and coordinate services including regulatory, monitoring, database development, insurance, and legal counsel. Guidance and support to facilitate study operations, ethics, contracts, and other site-level needs, from startup through closeout.

Provide epidemiological, biostatistical, and methodological expertise to study teams on their project.

Tools and resources to facilitate knowledge mobilization for your studies, including infographics and lay summaries for patients, families, and healthcare providers, communications, social media campaigns, and traditional academic outputs.

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.

Consultation and involvement of EDI+I team to integrate EDI+I principles into research. Language, cultural, and translation services.

Use the existing infrastructure of 6 decentralized biobanks to support biobanking studies.

Pan-Canadian group of research pharmacy personnel who function as a knowledge repository and advisory committee to help Investigators address challenges such as investigational drug procurement, compounding and placebo development, and various pharmacy challenges in conducting maternal and pediatric trials.