Quality and compliance are taking the reins to a greater extent than ever before as the driving forces behind the efficiency and profitability of any organization undertaking a clinical trial. This point was recently illustrated in an informative article by Patricia Santos-Serrao, a veteran regulatory and clinical expert and member of the Drug Information Association (DIA) and Regulatory Affairs Professional Society (RAPS). “The core aspects of quality – including training, document management, risk mitigation and quality management – can be used to provide efficiencies and improve quality of data throughout the clinical trial process,” Santos-Serrao says in the article. “Quality assurance, quality control and risk management are not simply for manufacturing.”
Establishing a Culture of Quality
The modern CQMS approach is about much more than just managing data. The new methodology is focused on acknowledging the importance of quality throughout the organization and ensuring that each department is firmly entrenched in a shared quality mindset. Quality is far more than just a departmental policing function, and market-leading companies thoroughly understand that fact.
“Such operations can look at the big picture,” Santos-Serrao says, “not just at managing the electronic data that is captured at the clinical site.” In addition, the current CQMS approach is now far more risk centered than it has been in the past, which provides the potential for companies to establish preconfigured thresholds that can be set in advance to identify and rectify problems earlier than ever before.
Another beneficial side effect of the comprehensive focus on quality is that it has enlightened the industry in regards to the importance of good communication and collaboration. After all, what one professional believes to be merely a standardized process, another professional may recognize as a best practice. A specialist may be executing tasks according to best practices and not even realize it, which is vital knowledge that could beneficial to anyone else assigned to fulfill similar tasks.
Key Components of Effective CQMS
There are three areas in particular that differentiate the holistic quality approach to clinical trial management from the traditional CTMS model.
1. Improved access to data: Efficient clinical management is completely dependent on getting the right information in the right hands at the right time. A strong link between clinical operations and the document management system is essential. A CQMS solution can provide this critical bridge.
2. Increased focus on training: What is the foundation for the actions you are taking? Thorough and suitable training of personnel is the difference between an organization that takes knowledgeable, informed actions and one that only makes inefficient, reactive responses.
3. Clinical CAPA: Have you ever heard manufacturing folks go on and on about “kappa” and wondered what in the world they’re talking about? CAPA, the acronym for corrective and preventative actions, is common shorthand in manufacturing circles but may be less familiar to those in other organizational departments. That shouldn’t be the case. Applying CAPA techniques to clinical operations can help study managers better mitigate risk and cope with exceptions more effectively.Guiding the Clinical Development Process into the Future
 Santos-Serrao, Patricia, “Action Packed,” Samedan Ltd. Pharmaceutical Publishers.
Accessed November 18, 2015.
James Jardine is a marketing communications specialist for MasterControl Inc.
He has a bachelor’s degree in journalism from the University of Utah and is
based in MasterControl’s headquarters in Salt Lake City, Utah.