Unpacking The Role of a Right-Sized QMS in Study Startup
The study startup process involves a multitude of tasks and activities multiple teams coordinate to ensure the successful study initiation.
qms
Clinical quality management systems (CQMS or QMS) are used in the life sciences sector (primarily in the pharmaceutical, biologics and medical device industries) designed to manage quality management best practices throughout clinical research and clinical study management. A QMS system is designed to manage all of the documents, activities, tasks, processes, quality events, relationships, audits and training that must be administered and controlled throughout the life of a clinical trial. The premise of a QMS is to bring together the activities led by two sectors of clinical research, Clinical Quality and Clinical Operations, to facilitate cross-functional activities to improve efficiencies and transparency and to encourage the use of risk mitigation and risk management practices at the clinical study level.
A Phased Approach to QMS
A phased approach to quality management systems (QMS) ensures quality is embedded at every stage, from discovery to post study.
Q&A: Stepwise Implementation of a Clinical Quality Management System
Advarra expert Steffen Engel answers questions from the recent webinar, Stepwise Implementation of a Clinical Quality Management System. Q: How
Implementing a Quality Management System
Many research and development (R&D) organizations across the industry have limited access to a quality department in the early stages of