Methodology
A structured approach to every engagement
Clintra QA uses a defined, risk-based methodology across all service types. Sponsors receive a scoped, evidence-based engagement with clear deliverables from day one.
Define objectives, regulatory context, study phase, vendor scope and agreed deliverables. All scope is confirmed in writing before work commences.
Critical processes and high-risk areas are identified and prioritised before fieldwork. Findings from previous audits or inspections are reviewed where available.
Structured review against applicable GCP requirements (ICH E6 R2/R3, sponsor SOPs, regulatory guidance). Evidence is documented and cross-referenced throughout.
Clear findings report with severity classification, root cause guidance, draft CAPA plan and effectiveness check wording. Delivered within the agreed timeline.
Principles
What to expect from every engagement
Scope confirmed before start
No work begins without a written, agreed scope. This protects your timeline and budget, and ensures the right areas are covered.
No sub-contractors
All work is completed personally. You receive the same senior consultant on every engagement, with full accountability for the deliverable.
Actionable findings only
Findings include regulatory basis, severity, root cause guidance and draft CAPA. Reports are written for sponsors, not auditors.
Selective by design
Capacity is controlled to maintain quality. Clintra QA does not over-commit. If the work cannot be done to standard, it is not accepted.