Clinical Quality Management System

A Quality Management System (QMS) is a system that outlines the policies and procedures necessary to improve and control the various processes that will ultimately lead to improved business performance.

 

 

While the manufacturing policies and procedures are documented early in a biopharma’s development, there is often a gap in creation and finalization and ongoing revision of clinical research policies and procedures due to competing priorities with managing the clinical trials. There must be set of sponsor-oriented standard operating procedures that will take the company’s clinical research into full-scale pivotal development and will support the activities of conduct and oversight of clinical trials with minimal risk of poor outcomes due to non-compliance and/or quality issues.

 

The art to SOP writing is to document enough detail to allow an employee to follow a given process consistently throughout the organization, but avoid the fine details that will cause the company unnecessary risk of non-compliance and the resulting issues ensuing in the event of a regulatory inspection. HCG has created or refined the Clinical Quality Management System throughout sponsor organizations of all sizes and stages.

 

Due to Halloran’s broad experience with FDA and Compliance Audit findings highlighting challenges with SOP interpretation, this technique will ensure the best quality final SOPs are implemented in the organization.