What we do. What we don't.
Know What MDTrials Delivers Directly - and What It Doesn't
Sponsors evaluating a specialty CRO need to know three things quickly: what we do ourselves, what we source through qualified partners under our oversight, and what we do not offer at all. Most organizations of our size leave the second and third categories to be discovered during a bid defence. We publish them.
This is not a limitation statement. It is how a focused CRO builds a credible operating model: depth in the functions we perform directly, documented partner arrangements for specialist functions, and no ambiguity about the boundary.
Delivery model
Delivered by MDTrials
- Clinical operations and study execution
- Clinical project management
- Clinical trial monitoring (on-site, remote, hybrid)
- Health Canada regulatory submissions and maintenance
- Research ethics submissions and continuing obligations
- Study start-up and site activation
- Site feasibility and selection support
- Essential documents and trial master file within contracted scope
- GCP audit and inspection readiness
- Vendor oversight within contracted scope
Through qualified partners, under MDTrials oversight
- Medical monitoring and safety physician cover
- Pharmacovigilance and expedited safety reporting
- Data management and EDC build
- Biostatistics and statistical programming
- Medical writing
- Central laboratory services
- Central imaging and independent review
- Specialist facilities where a protocol requires them
Not offered as a standard service
- Bedded healthy-volunteer clinical pharmacology
- Nonclinical and toxicology services
- Bioanalytical laboratory services
How partnered functions are governed
Where a function is delivered by a partner, the arrangement is documented before work begins: scope, responsibilities, reporting lines, and how MDTrials exercises oversight. ICH E6(R3) expects transferred activities to be documented in agreements and expects oversight of important activities transferred to service providers. Our operating model is built to make those responsibilities visible rather than blurred.
Sponsors may appoint their own providers for any partnered function. Where a sponsor does, we integrate that provider into the study operating model and coordinate accordingly.
What this means when you scope a program
At feasibility we produce an outline operating model for your study: which functions MDTrials performs, which require partners, which you may already have covered, and where the practical risks sit. That is a more useful starting point than a capability list, and it is how we prefer to open a sponsor conversation.
Frequent Questions
- Why do you publish what you do not do?Because a sponsor finds out eventually, and finding out during a bid defence costs both parties time. Publishing the boundary lets you scope accurately from the first conversation.
- Can we use our own vendors for partnered functions?Yes. Where you have a preferred provider for data management, biostatistics, safety or laboratory services, we integrate them into the study operating model rather than displacing them.
- Does using partners mean less accountability?No. Partnered functions are governed by documented agreements defining scope, responsibilities and oversight, consistent with ICH E6(R3) expectations for transferred activities. MDTrials remains accountable for the oversight it has contracted to provide.
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