Quality Assurance

We perform audits at all stages and on all processes used in the management of clinical trials and health related studies to assess adherence and compliance with SOPs, GCP, regulatory requirements, study protocols, client instructions and contractual obligations.

Our services include the following types of audit:

• Investigational site facilities
• Study data
• Trial master files and investigator site files
• Monitoring compliance
• Clinical trial documents including clinical trial reports

We can also provide the following ad-hoc services:

• Review of current structure and policies, processes and documentation
• Identification of corrective and preventive actions for process improvement
• Implementation of a comprehensive and efficient system enabling a consistent quality structure
• Writing, reviewing or updating SOPs