GCP Services

• GCP guidance & advice
• Contract Research Organisation (CRO) / Vendor audits (including archives)
• GCP system & process audits
• Phase I study, facility and quality management systems review
• Process evaluation, gap analysis and improvement services
• Quality Management System strategy advice & support (including the development of risk-based audit systems and performance indicators)
• Study documentation and in-life audits
• Clinical laboratory audits: bioanalysis, pharmacokinetic analysis, endpoint analysis, central laboratories, academic and research laboratories