Canadian start-up, without the guesswork
Start-up, planned as one picture.
A strong start-up plan aligns regulatory, ethics, contracting, documents, systems and site readiness rather than treating them as separate workstreams.
MDTrials CRO provides Canada-focused start-up execution and a single operational view of what is actually blocking activation.
Regulatory. Ethics. Contracts. Aligned
What we support
- Health Canada clinical-trial application and amendment support within contracted scope
- Regulatory document preparation, quality control and submission coordination
- Research-ethics submissions, amendments and continuing obligations
- Essential-document collection and trial master file start-up
- Investigator and site qualification documentation
- Clinical trial agreement and budget coordination with sites
- Site activation plans and readiness tracking
- Regulatory correspondence and maintenance through the study lifecycle
Canadian operating fluency
Our background is Canadian and Alberta-based. We work within Health Canada requirements and Canadian research-ethics processes, and we understand the practical dependencies between regulatory authorization, ethics approval, contracts, local site documents and readiness to enroll.
For Alberta studies, MDTrials can support applications and maintenance through the applicable research-ethics process. The board of record and institutional requirements depend on the study and site; we confirm the pathway for your study rather than promising a single route.
Frequent Questions
- How long does a Health Canada clinical trial application take?Review timelines depend on the application type and Health Canada's current performance against its service standards. We give an indicative timeline for your specific pathway at feasibility, and we plan ethics submission and site contracting in parallel so authorization is not the only gating item.
- Which research ethics board will review my study?That depends on the study, the sites and any institutional affiliations. In Alberta, studies may go through an institutional or a provincial research ethics pathway. We confirm the board of record during start-up planning.
- Can you support a non-Canadian sponsor with no Canadian entity?Yes. A sponsor based outside Canada can conduct a Canadian clinical trial, but the Canadian regulatory and import arrangements must be established for the specific study. Under current Health Canada requirements, a sponsor not based in Canada that imports trial drug must have a representative in Canada responsible for the applicable import and sale obligations. MDTrials can support the CTA, ethics, start-up and operational pathway within contracted scope; we confirm representative and importer responsibilities during scoping rather than assuming them.
CONTACT US
MDTrials coordinates CTA submission, REB review and contracts as one sequenced start-up plan, not separate workstreams.