GCP compliance and inspection readiness across the trial lifecycle, from protocol design through close-out, aligned to ICH E6(R3) and E8(R1), with direct health-authority experience.
Governing framework
E6(R3)
Good Clinical Practice, Principles & Annex 1
E6(R3) Annex 2
Decentralised, pragmatic & real-world designs
E8(R1)
General considerations, quality by design
FDA / EMA / MHRA
Regional adoption & inspection practice
What changed
ICH E6(R3) replaces a process-heavy, monitoring-centric rulebook with a principles-led framework. Quality is no longer something you inspect for at the end; it is designed in from protocol planning and managed in proportion to risk throughout the trial.
We translate that shift into the artefacts inspectors now expect to see: critical-to-quality factors, risk decision logs, and data governance that holds across every system and vendor in the trial.
How we work
One thread of GCP accountability from the first protocol draft to the closed-out, inspection-ready file. We embed where the risk is, scaled to the stage.
01 / Design
Quality by design
E8(R1) 3 · E6(R3) Principles 6
02 / Set-up
Sponsor accountability
Annex 1, 2 & 4
03 / Conduct
Risk-based quality management
Annex 1, 3.10
04 / Close-out
Inspection readiness
Annex 1, Appendix C
The operating model
The through-line connecting E8(R1) and E6(R3) is a single idea: decide what truly matters to participant safety and data reliability, then protect those things deliberately. Three mechanisms make it real.
01, Quality by Design
We work with your teams to identify, early in planning, the factors essential to participant protection and reliable results, then design processes that prevent errors rather than detect them after the fact.
E8(R1) 3.2 · E6(R3) 6
02, Proportionality
Oversight, documentation and data collection scaled to actual risk and importance, removing burden on participants and investigators where it adds no protection, and concentrating it where it does.
E6(R3) Principle 7
03, Data Governance
Defined data flows, traceability across systems and vendors, and quality control at each stage, proportionate to how much each dataset matters to safety and endpoints.
E6(R3) Annex 1, 4
Where we are different
Under E6(R3), inspectors increasingly want to see how quality was reasoned about, not just that procedures were followed. That means the evidence file looks different. We prepare the file regulators now ask for, drawing on direct experience inside health authorities.
Critical-to-quality factors, documented
A defensible record of what mattered and why, traceable to the protocol.
Risk & decision log
Identification, control, review and rationale: the reasoning, captured.
Quality management plan & QTLs
Pre-specified tolerances and the actions taken when signals breached them.
Mock inspection & readiness review
Story-board the file, rehearse the narrative, close gaps before the authority arrives.
Engagements
Scoped to your stage and risk, from a focused gap assessment to standing GCP advisory across a programme.
E6(R3) readiness
A structured review of SOPs, QMS and trial documentation against E6(R3) Principles and Annex 1, with a prioritised, risk-proportionate remediation plan.
QbD facilitation
Cross-functional sessions to identify critical-to-quality factors and design risk controls into the protocol before first patient in.
Inspection
Pre-inspection review, narrative preparation and mock inspections led by advisers with health-authority experience.
Oversight
Oversight frameworks and data governance that keep sponsor accountability intact across every delegated party and system.
Tell us about your product or programme and we will come back to you promptly.
