Quality Assurance and Control
The business of clinical trials is both complex and dynamic and, therefore, challenging. Quality and excellence is a vital component of any clinical trial and these values are embedded throughout the organisation.
Quality assurance begins and ends with the Director of International Projects and Planning who ensures that all clinical trial activities meet ethical standards and oversees audit and training procedures ensuring consistency at every Synexus centre.
The Synexus Quality Management System (SQMS) is also in place to constantly monitor data quality, provide ongoing staff training and encourage feedback from monitors and and patients, as well as to analyse Synexus' procedures.
Each Synexus centre collects feedback from its patients which is vital in maintaining high standards, and ensuring patient retention rates are achieves. The Monitor Feedback forms measure nine variables of customer satisfaction encompassing:
- Commitment from Principal Investigator
- Commitment from Research Nurse
- Commitment from Data Coordinator
- Quality of CRF completion
- Quality of source data completion
- CRF query resolution
- Quality of drug accountability records
- Quality of site file
- Availability of staff
Each of the areas use a grading scale from 1 (unacceptable) to 10 (excellent). The system was implemented in 2000 and achieves a response rate of 75%.