The quality management systems and activities at CTC are overseen by CTR´s Quality Assurance (QA) department, led by our experienced QA director.
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 guidelines as well as relevant regulatory requirements.
We are part of Swedish routine inspection of First-in-Human (FIH) unit program. In February 2019, our phase I unit was inspected by Swedish Medical Product Agency and was considered appropriated for performing FIH trials.
Whether it comes to clinical performance, deliverables, data integrity or subject data protection, quality and reliability is essential to us.
Similar to CTC, the QA unit is owned by the holding company Center for Translational Research (CTR) and hence acts as an independent function in relation to CTC. The unit performs audits of vendors used by CTC but also take on GLP, GMP and GCP audit assignments or performs QA services for other companies.
Catherine Trang Pham, Director Quality Assurance