Quality Management & QA
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.
Rethinking data quality
Pandemic-related disruptions have accelerated much-needed change in clinical operations, but this change has been accompanied by questions about data collection and data quality. These trials may require different approaches for collecting and managing data and complying with evolving regulatory guidance.
The ePremier CTMS is part of the Premier One Ecosystem, our system-agnostic data integration platform. Watch this video to learn how this powerful application brings together all your study data so that your Premier project team can provide you with deeper insights, automate administrative tasks, and generate critical reports.