Quality Assurance

Sonic Clinical Trials understands the importance of quality data and procedural compliance when conducting a clinical trial and we are committed to instilling the highest quality into everything that we do.

We understand that quality is a critical consideration when choosing a central laboratory. Through a comprehensive quality management program, we warrant compliance with ICH GCP and applicable local regulations. Sonic Clinical Trials adheres to strict regulatory requirements so that each client has confidence in the trial data and the selected central laboratory. Sonic Clinical Trials uses the world’s most advanced clinical trial and laboratory information management software to maintain comprehensive audit trails on all activities performed in the conduct of each clinical trial. We validate our electronic systems and processes to meet compliance with both TGA and US 21CFR11 requirements for electronic systems.

Sonic Clinical Trials is fully accredited for medical testing by the National Association of Testing Authorities (NATA) Australia, in conjunction with the Royal College of Pathologists of Australasia. Sonic Clinical Trials has led the way in becoming one of the first global central laboratories to be accredited to ISO 15189 (AS 4633), the definitive international standard for the accreditation of medical laboratories. ISO 15189 accreditation requires the laboratory to meet high standards in every aspect of operations, ranging from sample receipt through to sample analysis and reporting, assuring confidence in both our central laboratory management systems and technical competence.

Sonic Clinical Trials is also certified by the United States National Glycohemoglobin Standardization Program (NGSP), the accepted international standard for the performance of HbA1c.