Clinical Quality Assurance (CQA) Consulting

CQA Under ICH E6(R3) Inspection Readiness, BIMO,

and Risk-Based Oversight — US and Global

Click Here to Receive the Full CQA Readiness Checklist (PDF)

The Rules of Clinical Quality Have Changed

ICH E6(R3) changes the underlying principles of clinical quality assurance. It replaces prescriptive checklists with a risk-weighted framework. This new paradigm demands genuine quality by end-to-end design from protocol development through inspection. Sponsors must now maintain continuous inspection readiness, including real-time TMF (Trial Master File) oversight and routine audit trail review, throughout the full trial lifecycle.

Some sponsors are only discovering this gap when a BIMO inspector is in the room.

Where CQA Programs Commonly Break Down:

Vendor and site qualification processes built for E6(R2), not R3
TMF gaps that appear compliant until real-time review reveals otherwise
BIMO inspections exposing undocumented sponsor oversight decisions
Gap assessments that flag findings but don't map to corrective action
Ex-US sites operating under regional variations without harmonized QA oversight

What Landrich Offers (services list):

Inspection Readiness Programs (US FDA BIMO and ex-US)
ICH E6(R3) Gap Assessments
Vendor & CRO Qualification
Clinical Site Qualification & Oversight
Mock BIMO Inspections
QA SOP Development aligned to E6(R3)
Ongoing CQA support for active trials

Few firms know the new playbook

Landrich Does

ICH E6(R3) Clinical Quality Assurance Readiness Overview
Inspection Readiness Checklist for IVD & CDx Developers

Clinical Performance Studies · 510(k) / De Novo / PMA / CDx PMA · US FDA & Global

IVD and companion diagnostic (CDx) developers who sponsor clinical performance studies in support of FDA regulatory submissions. It covers study design quality, GCP compliance, trial master file readiness, site and vendor oversight, and BIMO inspection preparedness — framed specifically for device and diagnostic study sponsors, not drug sponsors.

Who This Checklist Is For:

FDA’s Bioresearch Monitoring (BIMO) program inspects the clinical studies that underpin IVD and CDx submissions — including 510(k), De Novo, PMA, and CDx PMA. Inspectors evaluate clinical sites, IRBs, and sponsor study management. Deficiencies found at inspection can delay or derail a submission already under review. Readiness is not optional.

Why BIMO matters for IVD/CDx companies:

Receive CQA Readines Checklist