The quality systems and activities at CTC are overseen by CTC´s Quality Assurance (QA) department, led by our experienced Chief Quality Officer.
Our quality framework includes a Quality Management System (QMS) with a risk-based internal audit program, a risk-based vendor assessment strategy, incident/complaint management and standard operating procedures (SOPs) written in compliance with applicable GxP and ISO standards as well as relevant regulatory requirements.
Our first-in-human (FIH) unit at Uppsala University Hospital is part of the Swedish routine inspection program. In February 2019, the unit was inspected by the Swedish Medical Products Agency and was considered appropriated for performing FIH trials.
Whether we are working on clinical performance and deliverables, safety of study subjects, data integrity or subject data protection, quality and reliability are essential to us. Read more about our quality assurance services.
Catherine Trang Pham, Director Quality Assurance