GCP/GMP Compliance and Auditing Services

Wakefield Clinical Research provides quality assurance and GCP compliance support for biotechnology, pharmaceutical, medical device, and IVD sponsors conducting clinical development in the United States.

Our approach focuses on practical, risk-based quality systems that support regulatory compliance, inspection readiness, and effective clinical trial execution.

• Quality Management System (QMS) development and improvement 
• SOP, policy, and work instruction development 
• Document control and change management 
• Training program development and documentation 
• Quality risk management 
• CAPA development and follow-up 

• Investigator site audits 
• CRO and vendor audits 
• Clinical trial process audits 
• GCP compliance assessments 
• Audit reports and CAPA follow-up 
• Inspection-readiness assessments 

• Protocol and study documentation review 
• TMF and regulatory file quality review 
• Protocol deviation and compliance review 
• Vendor and CRO quality oversight 
• Quality issue identification and escalation 
• Support for corrective and preventive actions 

Wakefield helps sponsors and study teams prepare for regulatory inspections through targeted document review, gap assessment, process evaluation, and inspection-readiness support.

Our quality services can be provided as standalone assignments or integrated with Wakefield's clinical operations and regulatory services. We tailor the level of support to the study, organization, and risk profile rather than applying a one-size-fits-all approach.

Preparing for an audit, inspection, or clinical trial? Contact Wakefield Clinical Research to discuss your quality and compliance needs.