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International Clinical Trials

The Optimisation of Clinical Quality Management Systems

ICT: How do you suggest organisations address the challenges of a clinical quality management system (CQMS) ecosystem divide?

Steve Whittaker: As with other industries, such as the financial industry, that are heavily regulated and use technology and integrated quality management systems, collaboration is necessary to establish process and software system standards that enable interoperability across organisations, systems, and purposes. This is especially true for electronic health records, electronic data capture, digital devices, and the use of other healthcare technologies. A concerted effort across all stakeholder groups, perhaps by consortia, will be necessary.

Do you think organisations have sufficient understanding of ICH E6(R2) requirements and are effectively implementing them? If not, what needs to be improved?

I believe most large pharmaceutical and provider organisations have adopted and integrated ICH E6(R2) requirements into their processes, operational tools, and software. Smaller pharma and biotech organisations have lagged in implementing process, tool, and software changes due to fewer resources available to devote the time required to adapt. Even when some of the organisations have adopted these appropriately, many still struggle with effectively implementing risk-based solutions driven by ICH E6(R2). This is because inadequate energy has been devoted to organisational change management (OCM) that reinforces and rewards risk prevention over issue management. Those that have been successful in adoption have made a concerted effort to address all components of the needed change, either by devoting internal resources or engaging consulting service organisations to drive rapid changes in processes, tools, systems, and OCM.

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About the Author

Steve Whittaker is a Senior Consultant with WCG Avoca and former Executive Director of the Avoca Quality Consortium®. He is also a lead consultant for the pharmaceutical, biotech, and CRO industries, providing expertise in project management, pharma development, clinical development, outsourcing strategies, and execution plans. His experience through years of drug development leadership roles, combined with his established professional network across these industries, provides unique and valuable insights for organisational leaders.
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