Canada-led CRO execution for emerging biopharma
Specialty clinical operations for emerging biopharma.
MDTrials CRO provides focused clinical-development execution for sponsors who want senior involvement, direct communication and a scope matched to the program.
Our work is Canada-led and concentrated in areas where our team has meaningful operating experience, including oncology, inflammatory bowel disease and hepatology.
Engage MDTrials for the function you need
Independent GCP audit and inspection readiness, clinical trial monitoring, regulatory/start-up and project management can be engaged as focused standalone services alongside your existing team or CRO. A Canadian study footprint is not required for independent quality and selected functional engagements.
What We Do
Early-Phase & First-in-Patient
Operational planning and delivery for early patient-cohort studies, including start-up, site execution, monitoring and coordination of specialized partners.
Clinical Trial Monitoring
Risk-based on-site and remote monitoring focused on participant safety, protocol compliance and reliable trial data.
Regulatory & Start-Up
Health Canada clinical-trial submission support, ethics coordination, essential documents and site activation.
GxP Audit & Inspection Readiness
Independent GCP-focused audits, vendor/process review and practical inspection preparation.
Project Management & Trial Technology
Study oversight, risk management, milestone control and fit-for-purpose trial systems with qualified human review.
Proportionate control. Senior access
Built for focused programs
Emerging sponsors need a CRO that is proportionate without becoming informal. MDTrials CRO combines defined project controls with direct access to accountable clinical-operations leadership, surfacing risks and difficult decisions early enough to act. A focused assignment can stand alone; broader Canadian execution can be added only where the program requires it.
Capacity confirmed before it's committed
Scope and capacity, stated up front
Study teams are scoped to the program rather than drawn from a standing bench. Monitoring capacity, visit frequency and site coverage are confirmed against the protocol at feasibility, and we will tell you at that point if a study requires more capacity than we can responsibly commit.
We publish a full delivery model showing which functions we perform directly, which we source through qualified partners under our oversight, and which we do not offer. Sponsors should not have to discover that during a bid defence.
Affiliated sites, never automatic
Working with MDTrials Sites
MDTrials Sites may be included in feasibility when a managed site fits the protocol. The CRO and site businesses remain separate legal entities. Affiliated sites are never automatic selections: the relationship is disclosed, selection remains sponsor-controlled, and roles are documented before work begins.
Our managed site network is currently anchored in inflammatory bowel disease and gastroenterology. Programs in other therapeutic areas, including oncology, are delivered through qualified external investigational sites.
Frequent Questions
- Do you work with sponsors outside Canada running Canadian studies?Yes. We can support non-Canadian sponsors that need a Canadian regulatory pathway, Canadian sites or local operational execution.
- Can I engage MDTrials for a single function rather than full service?Yes. Monitoring, regulatory and start-up, GxP audit and project management can each be contracted as standalone functional support alongside your existing team or CRO.
- What happens if my study needs a capability you do not provide directly?We tell you at feasibility, before contracting. Functions outside our direct scope are sourced through qualified partners under documented responsibilities and our oversight, or handed to a provider you appoint. Our delivery model page sets out exactly where those lines sit.
- How do you handle site selection when one of your own sites is a candidate?The affiliation is disclosed as soon as the site is proposed. The site is assessed against the same documented criteria as any other candidate, and the final selection decision is the sponsor's and is recorded as such.
- Does my study need to be in Canada to work with MDTrials CRO?No. Independent GCP audit / inspection-readiness and selected functional engagements can support programs without a Canadian study footprint. Canada becomes relevant when regulatory, monitoring, site or local operational work is in scope.
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Introduces MDTrials CRO's specialty clinical-operations model for emerging biopharma, sets the scope boundary up front, and routes sponsors into the five core CRO services.