Specialist QA &TMF AuditConsultancy
Senior GCP QA support for sponsor-led clinical trials. Vendor oversight, inspection readiness, TMF/eTMF audits and SOP/QMS development — delivered with rigour and without compromise.
Services
Where Clintra QA can support you
TMF / eTMF Audits
LimitedTMF completeness, quality, timeliness, filing logic, audit trail and inspection readiness. Covers both paper and electronic TMF systems.
SOP / QMS Development
OpenCreation or refinement of GCP SOPs, templates, forms and controlled processes. Gap analysis against current QMS and regulatory guidance.
Inspection Readiness
LimitedTargeted support to prepare sponsor teams and study files for regulatory inspection. MHRA, FDA, EMA and other health authority contexts.
Methodology
A structured, risk-based approach to every engagement
Every engagement follows a defined lifecycle — scoped, executed and closed with evidence.
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.