Independent audit. Usable evidence
Know Where You Stand Before an Inspector Does.
Independent audit support for sponsors, sites and clinical service providers — scoped to the risk, process and standard being assessed.
The goal is usable evidence of oversight and corrective action, not a generic checklist.
Independent GCP audit and inspection-readiness support for emerging biopharma, sites and clinical service providers. Engagements can be scoped to a single site, vendor, process, TMF or readiness question — and do not require a Canadian study footprint or a specific therapeutic-area match.
Core audit and readiness scope
GCP / Investigator Sites
Site conduct, essential documents, protocol and GCP processes, and readiness for sponsor or regulatory inspection.
Clinical Operations / Monitoring
Monitoring processes, reports, follow-up, escalation and documented sponsor oversight.
TMF / Essential Documents
Completeness, quality, filing processes and traceability of trial records.
Vendor Qualification / Oversight
Risk-based qualification and oversight of clinical service providers within the agreed audit scope.
Computerised Systems / Data Integrity
Review of selected system governance, access, audit-trail and validation controls where within auditor qualification and scope.
Mock Inspection / Gap Assessment
Structured readiness review, issue prioritization and practical CAPA preparation.
Independent by design. Every time
How an engagement runs
Define scope → Plan → Audit or assess → Report → CAPA support → Effectiveness follow-up.
Audit activities are assigned so the person assessing a process is independent of the operational activity being audited. Where an MDTrials Sites location is within scope, independence and reporting arrangements are defined before the audit begins.
Frequent Questions
- How do I prepare for a Health Canada GCP inspection?Preparation usually starts with a gap assessment against the areas an inspection examines — organization and personnel, quality systems, training, essential documents and archiving, monitoring, contracts, safety and computerized systems. We run a structured readiness review, prioritize findings, and rehearse the process with the team who will be in the room.
- Do you audit vendors and service providers as well as sites?Yes, within the agreed scope. Vendor qualification and oversight audits are part of our GCP-focused scope.
- Can you audit GMP, GLP or laboratory operations?Those are assessed case-by-case against our current auditor qualifications rather than offered as a standing service. If a scope falls outside what we can properly staff, we will tell you.
CONTACT US
Independent GCP audits across sites, vendors and TMF give sponsors a documented view of inspection readiness ahead of time.