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[1], 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.” |
Monday, 23 November 2015
Holistic CQMS: The Modern Model of Clinical Trial Management
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