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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.

 
Webinar

Growth Mode: Developing a Fit-for-Purpose QMS Model

Upcoming: October 6

Learn successful strategies for a stepwise implementation of a clinical QMS, tailored to companies in growth mode.

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Blog

Q&A: Stepwise Implementation of a Clinical Quality Management System

Advarra expert Steffen Engel answers questions from the webinar, Stepwise Implementation of a Clinical Quality Management System.

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8 min. read
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Webinar

Stepwise Implementation of a Clinical QMS

The webinar dives into current QMS challenges and recommend strategies to advance successful QMS programs across your enterprise

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Blog

Steps to Implementing a Quality Management System

Read our blog to learn more about quality, its role in clinical research, and how to implement a management plan.

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3 min. read
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White Paper

Steps to Implementing a Quality Management System

This white paper outlines the full implementation process of a quality management system and how to avoid conflict by focusing on quality.

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