Quality Management & Quality Assurance
Uncompromising quality demands an experienced quality management team and sophisticated technology. We’ve got both.
A full range of auditing tools
Services that ensure the integrity of your studies
The growing level of regulatory stringency in drug development demands quality assurance at the highest level – no shortcuts, no compromises.
Our global Quality Management Systems and Quality Assurance group recognizes this need and provides a full range of services to ensure the integrity of your studies. We offer:
- Investigative site audits
- Trial master file audits
- Database audits
- Clinical study report audits
- Statistical report audits
- Vendor audits
In addition to providing study-specific auditing services to sponsors, our quality management team follows a thorough internal audit schedule.
Planning for quality
Risk-based monitoring is a comprehensive approach to clinical trial monitoring that focuses on proactively identifying and addressing risks to patient safety and data quality. Effectively navigating the shift from traditional to risk-based monitoring requires collaboration and careful planning.