The life science industry is experiencing a transformation in the clinical trial management paradigm. The timeworn clinical trial management system (CTMS) archetype is being increasingly supplanted by a more comprehensive and efficient clinical quality management system (CQMS) model.
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.”
Injecting new life into a tired CTMS by incorporating proven quality methodologies can provide a host of benefits. Increased data integrity, better deviation prevention, improved risk mitigation, more control over corrective actions, reduced costs and streamlined operations are just a few of the perks of implementing a CQMS.
For additional information on how CQMS software can enhance clinical trial management, download a complimentary copy of the MasterControl Clinical Suite™ product data sheet.
 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.
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