Quality and continuous improvement should be at the heart of everything we do in clinical research and is vital to the safety of patients, the delivery of reliable science and data integrity in the development of new medicines, devices or diagnostic tools.

Quality assurance applies to all systems, procedures, activities and personal involved in the planning, running, validating, analysing and reporting of clinical trials.

Consultancy services include:

• Review of internal quality management systems and gap-analysis
• Risk management
• Corrective and preventative actions including handling of inspection or third party audit findings
• Clinical equipment management and validation; computerized system compliance requirements
• Standard Operating Procedures (SOP), controlled forms and templates
• GCP essential document review
• Inspection readiness training
• Pre-inspection support and preparedness
• Training records
• Training programs