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A smiling female clinical research professional in a navy suit stands in a modern office, holding a tablet displaying data next to a large monitor showing a clinical trial process flow diagram.

Clinical Trials, GxP Auditing5 days ago

Quality Management Systems in Australian Clinical Trials: Sponsor Responsibilities

GxP auditor reviewing clinical trial data on a laptop in a controlled laboratory or clinical research environment, supporting regulatory compliance and audit readiness.

GxP AuditingJanuary 26, 2026

GxP Auditor in Australia: What is the makeup of a GCP Auditor in Australia.

Quality assurance professional reviewing pharmaceutical technical documentation to ensure GxP compliance, ALCOA+ data integrity, and inspection readiness.

Business, GxP AuditingJanuary 21, 2026

Good Technical Writing in Pharmaceutical Arena: Your Complete Excellence Guide

Australian clinical trial professionals reviewing GCP data management records on validated systems, demonstrating ALCOA+ data integrity and TGA inspection readiness under ICH E6(R3).

GxP AuditingJanuary 19, 2026

Data Management and Good Clinical Practice – An Australian Perspective

A professional reviewing printed documentation at a desk in a modern office environment, focused and engaged

Business, GxP AuditingJanuary 15, 2026

Good Document Practice – Pharmaceutical Industry Considerations

Two professionals reviewing clinical research data, charts, and regulatory documents together at a desk using a laptop.

GxP AuditingJanuary 1, 2026

GCP Consultant Australia: 20 Good Clinical Trial Updates for 2025 That Should Be Shared

A warmly lit desk scene with a laptop, calculator, coffee cup, and scattered papers, featuring an “AI” labeled round device sitting on top of hand-drawn workflow notes and a checklist that includes “Production” and “Decision.”

AI Hub, GxP AuditingDecember 26, 2025

Why AI Projects Fail to Deliver ROI: A Practical Path to Move Past Pilots and Prove Value

Infographic illustrating key steps for transitioning to ICH E6(R3), including CtQ identification, RBQM maturity, sponsor oversight, and inspection-ready training.

GxP AuditingDecember 25, 2025

ICH GCP E6(R3) vs R2: Modernising Trials With Control

Human interacting with an AI interface, representing Human-in-the-Loop AI oversight where qualified professionals review, validate, and control AI-driven decisions in regulated environments.

AI Hub, GxP AuditingDecember 23, 2025

Human-in-the-Loop AI: The Regulatory Control for GxP

Clinical operations professional reviewing regulatory documentation while analysing validation and performance data on a laptop dashboard

AI Hub, GxP AuditingDecember 22, 2025

Computer System Validation in Clinical Trials

Professionals reviewing inspection readiness and Part 11 documentation alongside a validated digital system in a regulated environment

GxP AuditingDecember 21, 2025

Understanding 21 CFR Part 11 Requirements

Two clinical operations professionals standing beside a large screen reviewing risk-based monitoring dashboards and critical-to-quality factors for ICH E6(R3) implementation.

GxP AuditingNovember 30, 2025

Navigating 2026 ICH E6(R3) Implementation in Australia: Your Quality Management Transformation Guide