Patient safety and quality data underpin everything we do. Our quality team ensures that our processes are robust and patient data is complete and accurate.
We are recognised as a leader in quality assurance and compliance across multiple international investigator sites. We have developed our own Synexus Quality Management Systems to ensure rigorous regulatory and ethical compliance.
We continuously work with sponsors and regulators to update our operating procedures, providing a continuum of process improvements that ensures compliance with regulatory, ethical and ICH GCP requirements and expectations.
The Synexus Quality Management Structure (see diagram) ensures that rigorous procedures, controls, metrics and training are embedded within our processes, informed by our Quality Vision – To continuously achieve the best quality standards to provide the highest service to customers and patients.
Our team of highly experienced quality auditors and operational quality staff promote excellence in our clinical research through quality assurance and compliance services provided to the individual studies and clinical centres.
The Synexus Solution
1. Quality Vision
Continuously achieve the best quality standards to provide the highest service to customers and patients.
2. SOPs & Templates
Comprehensive set of Standard Operating Procedures covering all key processes aligned across all sites and the business.
3. QA and QC controls
Quality Assurance – system and trial specific sampling checks are performed by both internal and external auditors. Quality Control: local checks on clinical trial management and data.
4. Employee training
Annual GCP training is conducted for all staff. Mandated regulatory training, study training, therapeutic specific training and leadership/management training are provided as required.
5. Performance metrics
Analysis of feedback from client monitors, project managers and patients. Employee performance management.