Independent, expert auditing of clinical trials across all development phases. Rigorous, insightful, and focused on what matters.
Independent auditing is a cornerstone of an effective GxP quality system. Our audit services provide sponsors, CROs, and academic institutions with objective, expert assessment of their clinical trial processes, documentation, and systems — delivered by an experienced auditor with a deep understanding of regulatory expectations.
We conduct audits across all phases of clinical development (I–IV) and across the full spectrum of audit types required by ICH E6(R3), EU CTR and associated guidelines. Our reports are clear, actionable, and calibrated to the risk and context of each audit.
To discuss your audit requirements or request a proposal, please get in touch. We will work with you to scope an audit programme that fits your needs and timeline.
Get In TouchComprehensive audit coverage across the systems, processes, and documentation required for GxP-compliant clinical research.
On-site audits of clinical investigator sites, assessing protocol compliance, consent processes, data integrity, delegation of duties, and site facility standards across Phases I–IV.
Qualification and ongoing oversight audits of contract research organisations, central laboratories, IVRS/RTSM providers, data management vendors, and other third-party service providers.
Audit of Trial Master Files (paper-based or electronic) against applicable ICH and regulatory requirements. Assessment of completeness, quality, and retrieval readiness for inspection.
Audits of clinical data management processes, EDC systems, data validation rules, audit trails, and CDISC compliance. Assessment of data integrity controls and 21 CFR Part 11 / Annex 11 compliance.
Review and audit of Clinical Study Reports prior to regulatory submission, verifying accuracy, consistency with the protocol and statistical analysis plan, and compliance with ICH E3 guidelines.
Specialist audits of Phase I clinical pharmacology units, including safety monitoring processes, subject recruitment, IMP accountability, and early-phase trial-specific requirements.
Assessment of clinical trial archive facilities against GCP and sponsor requirements — covering physical conditions, security, document retrieval, and records retention compliance.
Structured mock MHRA, EMA, or FDA inspection to assess readiness, identify weaknesses, and prepare your team for the process and expectations of regulatory inspectors.
Internal audits of sponsor quality systems, pharmacovigilance processes, clinical operations, and regulatory affairs functions — supporting continuous improvement and inspection readiness.
We conduct audits across the United Kingdom and internationally, with experience of sites and organisations across Europe and beyond.
Remote and virtual audit formats are also available where appropriate and agreed with the auditee.
Sponsor organisations conducting clinical trials of all sizes and development stages, from small biotechs to established pharma.
CROs requiring independent audit of their systems, processes, and performance in support of sponsor obligations or their own quality programme.
Universities, NHS Trusts, and charitable research organisations conducting IMP or non-IMP clinical investigations.
Audit Standards & Regulatory Frameworks
A structured, transparent audit process — from initial scoping through to CAPA follow-up.
We work with you to define audit objectives, scope, and timing, tailored to your risk priorities and programme needs.
Thorough, professional audit conducted on-site or remotely, following a structured audit plan and ICH E6(R3) principles.
Clear, risk-rated audit report delivered promptly, with findings categorised and actionable CAPA recommendations provided.
Support for auditees and sponsors in developing and verifying CAPA responses — closing findings effectively and on time.