Good Clinical Practice (GCP) Audit Services
GCP audits are a critical component of clinical trial quality assurance, helping sponsors, CROs and healthcare organisations evaluate compliance with ICH GCP requirements and global regulatory expectations.
Tower Mains provides independent GCP audit services across the clinical development lifecycle, using a practical, risk-based approach to identify risks, strengthen oversight and support inspection readiness. Our experienced auditors cover investigator sites, CROs, vendors, clinical systems, trial documentation, data processes and quality assurance activities, providing clear findings and practical recommendations tailored to your needs.
Why GCP audits matter
A robust GCP audit programme helps organisations maintain effective oversight of clinical trial activities, protect data integrity and support the delivery of high-quality clinical research. Without appropriate GCP oversight, organisations may face:
Regulatory findings or observations during regulatory authority inspections.
Data integrity, documentation or process weaknesses.
Insufficient oversight of CROs, vendors and other third parties.
Delays to clinical development programmes.
Increased corrective action requirements and operational impact.
Tower Mains helps organisations proactively identify and address these risks through independent GCP audits, providing clear insight and practical recommendations to strengthen quality systems and inspection readiness.
Our GCP audit services
Tower Mains provides flexible GCP audit solutions to support sponsors, CROs and clinical research organisations throughout the trial lifecycle. Our audits are tailored to your requirements and delivered using a risk-based approach aligned with ICH GCP and applicable regulatory expectations.
Investigator site audits
- Routine, targeted and for-cause investigator site audits (Phase I–IV)
System audits
- Internal
- Third Party Activities
Vendor audits
- CROs
- Phase I Units
- Monitoring & Project Management
- Data Management, Biostatistics & Medical Writing
- Clinical Trial Supply
- Archive Facility
- Imaging Facilities
- Statistics
Computer System Validation (CSV) audits
Data management audits
- Database
- Data Management System
Trial Master File (TMF) audits
- TML Audit (paper and electronic)
Document audits
- Protocol
- Case Report Forms
- Informed Consent Forms
- Investigator’s Brochures
- Clinical Study Reports
- Development Safety Update Reports
- Clinical Plans including Management, Risk Management & Monitoring Plans
Our GxP audit process
Tower Mains applies a practical, risk-based approach to GxP auditing, ensuring each audit is delivered by a specialist with the appropriate technical expertise and regulatory knowledge.
1. Understanding your requirements
We begin by understanding your objectives, audit needs, timelines and key areas of focus.
2. Selecting the right GxP auditor
We assign an auditor with relevant GxP expertise, industry experience, technical knowledge and an understanding of your specific requirements.
3. Preparing for your audit
Your auditor prepares the audit plan, agenda and documentation requirements.
4. Conducting the audit
Audits are performed remotely or on-site through interviews, document reviews and assessment of relevant systems, processes, facilities, suppliers or studies.
5. Delivering clear audit outcomes
You will receive a comprehensive audit report, prepared using your preferred format or our own template, detailing observations, findings and practical recommendations for improvement.
6. Follow-up and ongoing support
Where required, we provide follow-up activities including CAPA review, re-audits and additional quality assurance support.
Why choose Tower Mains?
Global GxP Expertise
Access experienced auditors, quality professionals and subject matter experts across the GxP landscape, from clinical and laboratory environments to manufacturing, devices and research. We bring industry experience and specialist insight to help you address quality and compliance priorities.
Regulatory and Technical Insight
Our team brings extensive, real-world experience across global regulatory frameworks, including ICH, FDA, EMA and MHRA requirements. We help organisations interpret regulatory expectations, focus on what matters, assess risk and make informed quality decisions with confidence.
Flexible Quality Solutions
From single audits and annual audit programmes to vendor oversight, QA support and inspection readiness, we provide the right support for your objectives and risk profile. Services can be delivered in person, remotely or through a hybrid approach.
Practical. Proportionate. Collaborative.
We believe quality should enable your organisation, not add unnecessary complexity. Working alongside your teams, we bring an objective perspective, provide constructive challenge and help strengthen quality systems through sustainable improvements.