Canadian trial support, grounded in the framework
Every Trial, Run Within a Named Regulatory Framework.
MDTrials' Canadian clinical-trial work is conducted within the legal, regulatory, ethical and contractual requirements applicable to the study and service being performed.
Core framework.
MDTrials Canadian clinical-trial work is performed within the legal, regulatory, ethical and contractual requirements applicable to the study and to the role we have been assigned.
For drug trials this includes Part C, Division 5 of the Food and Drug Regulations, current Health Canada guidance, ICH E6(R3) Good Clinical Practice, applicable research-ethics requirements, and the protocol and study agreements.
The rules we work within
Research ethics
Clinical-trial activities begin only after the required regulatory and ethics conditions for the study and site are satisfied. MDTrials supports the submission, maintenance and documentation responsibilities assigned to its CRO or site role.
Participant protection
Informed consent, safety reporting, investigator oversight and protection of participant rights are foundational GCP requirements. Commercial or operational pressure does not override participant safety or the reliability of trial data.
Indigenous research governance
Where research involves First Nations communities or First Nations data, applicable Nation-specific governance and the First Nations principles of OCAP(R) should be considered where relevant. Inuit and Metis research should follow the governance frameworks applicable to those communities rather than being described under OCAP(R). Community-level agreements and data-governance requirements are confirmed before study activation when applicable.
Frequent Questions
- What regulations govern clinical trials in Canada?Drug clinical trials are governed under Part C, Division 5 of the Food and Drug Regulations, together with Health Canada guidance and ICH E6(R3) Good Clinical Practice, which Health Canada implemented on 1 April 2026. Research ethics review and, where applicable, TCPS 2 also apply.
- Do you support device studies?Where device clinical investigation requirements are within the agreed scope, yes. Device work is secondary to our drug-development focus.
- Does a non-Canadian sponsor need a Canadian entity?Sponsor obligations under Canadian regulations must be met regardless of where the sponsor is based. We advise on the practical arrangements during scoping; specific legal structuring should be confirmed with your regulatory counsel.
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