Novella Clinical’s quality management processes are integral to all aspects of our business. Our independent Quality Assurance department performs regular quality assessments of our services to ensure compliance with the Food & Drug Administration (FDA) and applicable regional local regulations, as well as ICH Guidelines. Novella’s Quality Affairs department facilitates our Quality Management System (QMS) worldwide and oversees Novella’s certification to the ISO 9001:2008 Quality Management System Standard. This certification requires a focus on meeting customer expectations and delivering customer satisfaction. The Quality Affairs department provides QMS oversight in relation to SOPs, continuous improvement, and GCP compliance consulting.
Our experienced auditors conduct project audits that have been contracted or those that are part of our routine cycle. Project audits can include the trial master file, investigator clinical sites, clinical study reports, and documentation processes, providing peace of mind for customers. In addition, our Quality Assurance team operates a robust vendor qualification process and regularly conducts vendor audits to ensure all of Novella’s vendors meet or exceed our stringent standards.
In fact, Novella’s commitment to quality facilitated our North American headquarters to earn ISO 9001 certification in 2004, and recertification in 2010, 2013 and 2016. Each Novella location, worldwide operates under our centralized quality management system.
View our Quality Policy here.