TMF & documentation review
Trial master file completeness and quality reviews that identify gaps before an inspector does, informed by our investigator site audits practice.
What's included
What the assessment covers
- Full TMF completeness and quality review against the study's filing plan
- Gap identification and remediation tracking before the real inspection window opens
- A mock inspection run against the same scope and tempo as a real health authority visit
- Staff and site coaching so study teams know what to expect and how to respond
- Findings from our own auditing engagements fed directly into the readiness assessment
Mock inspections
Site and sponsor-level mock inspections and staff coaching that build confidence ahead of a real health authority visit.
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