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TMF/ISF Cleanup & Inspection Preparation

Bring your Trial Master File and Investigator Site Files into inspection-ready shape – with a practical, risk-based approach.

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1 

What this service does

Regulators and sponsors are increasingly strict about TMF/ISF quality. Missing, inconsistent or inaccessible documents can quickly become major findings.

This service focuses on a specific study and helps you:

  • Assess TMF and ISF completeness and consistency

  • Prioritise remediation work

  • Prepare teams for audits and inspections

2

Who it’s for

  • Sponsors or CROs expecting an audit or inspection

  • Biotech, MedTech or Diagnostics companies closing a key study

  • Organisations with hybrid paper/digital TMF/ISF history

3

What we do

  • TMF completeness check using a recognised reference structure (e.g. DIA/EMA)

  • ISF sampling across selected centres to check alignment with the TMF

  • Identification of document gaps, duplicates and inconsistencies

  • Review of access rights, audit trails and export options for digital systems

  • Recommendation of quick-win fixes vs. structural issues

  • We also consider how your Clinical Data Systems (CDS) contribute evidence (logs, exports, reports) for inspectors.

4

Deliverables & Outcomes

You receive:

  • A TMF/ISF gap analysis report for the selected study

  • A prioritised remediation list (what to fix first, and how)

  • A short CAPA proposal you can integrate into your QMS

  • One mock Q&A session (script and talking points) to prepare your team

 

You will:

  • Have a much clearer picture of your inspection risk

  • Be able to focus resources on what matters most

  • Increase confidence of your teams when audits or inspections are announced

  • Use the experience to improve TMF/ISF practice across future studies

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