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 works closely with study sponsors and researchers to ensure services follow strict adherence to clinical protocols which have been approved by independent ethics committees; testing and services only occurs after client has confirmed informed patient consent has been granted. The management and medical team reviews each clinical protocol at periodic feasibility meetings to consider risk and impact assessment prior to study commencement. Ongoing monitoring and oversight of all studies undertaken is an essential management review requirement.
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 and 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 in accordance with ISO 15189. Sonic Clinical Trials is also certified by the United States National Glycohemoglobin Standardization Program (NGSP), the accepted international standard for the performance of HbA1c and CDC Lipids.