ARO Post-Award Services
Assisting Studies to Completion
MICYRN’s expanded post-award service offerings are designed to meet current needs while supporting institutions in building their own local clinical trial capacity. These services are provided on a cost-recovery basis.
Protocol Development
MICYRN supports the transition from funded applications to Health Canada-compliant clinical trial protocols through access to experienced protocol writing expertise and operational guidance.
Health Canada Regulatory Submissions
We prepare and submit Clinical Trial Applications (CTAs) for regulated studies, including drug, natural health product, and cannabis trials, as well as Investigational Testing Authorizations (ITAs). MICYRN also supports adverse event reporting and ongoing regulatory compliance activities.
Centralized Ethics Submissions
MICYRN provides consultation and operational support for pediatric clinical research ethics submissions, including preparation and coordination of multi-jurisdictional applications to support streamlined and timely approvals.
Monitoring
MICYRN develops and implements risk-based clinical trial monitoring plans and provides dedicated monitoring personnel in alignment with Health Canada regulations and sponsor requirements.
Quality Assurance
Our Quality Assurance (QA) Lead collaborates with member sites to develop and implement QA strategies that promote high-quality trial conduct and support audit and inspection readiness throughout the study lifecycle.
Data Safety Monitoring Boards (DSMBs)
MICYRN supports DSMB operations through member identification, charter development, meeting coordination, agenda and minutes preparation, and report distribution.
Data Management
MICYRN supports the development of clinical trial databases and provides data management services using validated systems. Services include case report form development, Data Management Plans (DMPs), and data workflow design to support high-quality data collection and oversight.
Project Management
We provide flexible clinical trial project management support ranging from targeted post-award resourcing to comprehensive day-to-day study coordination. Services span study start-up through close-out and include coordination across regulatory, ethics, monitoring, and data management functions.
Research Pharmacist Network
MICYRN leads a pan-Canadian network of research pharmacists with expertise in drug procurement, compounding, placebo development, and other pharmacy-related considerations for maternal and pediatric clinical trials.
Biostatistical Design & Analysis
We facilitate access to expert biostatistical support to strengthen study design, methodological rigor, and data analysis.
Knowledge Translation & Communications
MICYRN supports the communication and dissemination of research, programs, and network initiatives through strategic storytelling, plain-language content, digital communications, and audience-focused resources designed for researchers, patients and families, partners, and healthcare providers.
Patient & Family Engagement
We facilitate meaningful collaboration with patient and family partners to help ensure study materials, including protocols, consent forms, and recruitment resources, are accessible, inclusive, and patient-centred.
Administration, Finance & Governance Support
MICYRN provides flexible and scalable administrative, financial, and governance support for grants, platforms, research groups, and networks. These services help strengthen long-term sustainability, streamline operations, and reduce disruptions associated with transitioning support across institutions
For more information about these services, please fill out our intake form.