Protocol Development

MICYRN supports the transition from funded grant applications to Health Canada-compliant clinical trial protocols.

Health Canada Regulatory Submissions

We prepare and submit clinical trial applications (CTAs) and Investigational Testing Authorizations (ITAs) for regulated clinical trials. MICYRN also provides training and mentorship to institutions aiming to develop local regulatory submission capacity.

Centralized Ethics Submissions

In collaboration with the Canadian Collaboration for Child Health: Efficiency and Excellence in the Ethics Review of Research (CHEER) and institutional Research Ethics Boards (REBs), MICYRN offers consultation for pediatric clinical research ethics submissions. We support application preparation for multi-jurisdictional trials to ensure efficient and timely approvals.

Information Sheet

Monitoring & Quality Assurance

MICYRN develops and implements clinical trial monitoring plans and provides dedicated personnel for risk-based monitoring in compliance with Health Canada and sponsor requirements.

Our Quality Assurance (QA) Lead works with member sites to develop QA strategies that maintain high standards and ensure audit and inspection readiness throughout the trial lifecycle.

Data Safety Monitoring Board

We assist with DSMB member identification, charter development, meeting coordination (scheduling, agendas, minutes), and report distribution. MICYRN also supports adverse event reporting to Health Canada.

Data Management

MICYRN facilitates the creation of clinical trial databases and provides data management support using validated REDCap platforms. We assist with the development of case report forms and data workflows.

Project Management

We offer high-level project management to bridge resourcing gaps post-award and, where needed, full day-to-day study execution support. Services include coordination across regulatory, ethics, monitoring, and data teams, from study start-up through close-out.

Research Pharmacist Network

MICYRN leads a pan-Canadian network of research pharmacists who offer expertise in drug procurement, compounding, placebo development, and other pharmacy-related challenges in maternal and pediatric clinical trials.

Biostatistical Design & Analysis

We provide expert biostatistical support for robust study design and accurate data analysis.

Knowledge Translation & Mobilization

MICYRN supports the dissemination of research findings through tools such as infographics and plain-language summaries for patients, families, and healthcare providers.

Patient & Family Engagement

We facilitate meaningful collaboration with patient and family partners to ensure study materials, such as protocols, consent forms, and recruitment tools, are inclusive, accessible, and patient-centred.

For more information about these services, please fill out our intake form.