CAP, CLIA & ISO Accreditations

CAP/CLIA accreditations are internationally recognized quality credentials for clinical laboratories. For sponsors, it means CellCarta's laboratory processes, personnel qualifications, equipment, and test performance have been independently reviewed and meet the rigorous standards set by CAP/CLIA. Data generated in a CAP-accredited, CLIA-certified lab is widely accepted by regulatory agencies including the FDA and EMA.

CellCarta maintains rigorous accreditation standards across its global network. All six of our labs — Antwerp (Belgium), Gosselies (Belgium), Jining (China), Lake Forest (USA), Montreal (Canada), and Naperville (USA) — hold CAP accreditation. Our sites in Antwerp (Belgium), Lake Forest (USA), Montreal (Canada), and Naperville (USA) additionally hold CLIA certificates of accreditation.

CellCarta has a global presence of ISO certified laboratories. The Antwerp clinical laboratory holds ISO 15189 and ISO 13485 certifications. The Naperville laboratory and logistics facility in Antwerp also hold ISO 13485 certification. ISO 27001 ISMS certification is maintained across all our global sites (Antwerp, Gosselies, Baulkham Hills, Jining, Montreal, Naperville) to protect clinical trial data and proprietary assay information.

CellCarta's QMS is implemented at all organizational levels under GCP, GLP, and GCLP regulations, covering study planning through data archiving. All processes are performed by qualified personnel and recorded in controlled documents including SOPs, Client Specific Procedures, and study worksheets that are approved prior to use. QA audits are performed by a dedicated Quality Assurance Unit to monitor performance and identify improvement opportunities.