Quality you can verify, not just trust
Quality is what survives pressure.
Quality is demonstrated by the controls that remain in place when a study is busy, a site is under pressure, or an inspection happens later.
MDTrials is building its operating model around documented responsibilities, risk-based quality management, controlled records and traceable oversight.
This section is written for sponsor clinical-operations and quality teams. It explains what is controlled and how responsibilities are separated, rather than relying on generic statements that MDTrials meets the highest standards.
Five pillars. One quality posture
Quality Management System
How risk-based quality management, training, document control, deviations, CAPA and vendor oversight are governed.
Data Integrity & Computerised Systems
How electronic trial information is controlled across access, validation, audit trails, change and retention.
Structure & Operational Independence
How MDTrials CRO and MDTrials Sites remain separate when both support the same study.
Clinical Trial Regulatory Framework
The Canadian GCP, Health Canada and ethics framework relevant to the services we provide.
Privacy & Information Governance
How privacy obligations are determined by the information, jurisdiction and relationship.
Documentation ready for your audiT
Sponsor qualification
Sponsors conducting vendor qualification can request the documentation appropriate to the scope being considered, such as organizational information, insurance, selected quality-system documentation, SOP indices, training evidence, governance documentation and other qualification materials, subject to confidentiality controls.
Frequent Questions
- What changed in ICH E6(R3)?E6(R3) places explicit emphasis on risk-based, quality-by-design conduct — identifying factors critical to quality, applying proportionate controls, and documenting the responsibilities transferred to service providers. It also expands expectations around computerized systems and data governance across the data lifecycle. Health Canada implemented E6(R3) on 1 April 2026.
- What documentation can we request for vendor qualification?Organizational information, insurance, selected quality-system documentation, SOP indices, training evidence and governance documentation, scoped to the engagement and subject to confidentiality controls.
- Are you certified to any quality standard?We operate a documented quality management system aligned to ICH E6(R3) principles. We do not claim certification we do not hold, and we will tell you precisely what is in place during qualification.
CONTACT US
MDTrials quality management, data integrity, computerized-system governance, CRO and site independence, and the Canadian clinical-trial regulatory framework.