Cultivating quality excellence in the clinical trials landscape


Quality is subjective, with different individuals associating it with various things. However, when seeking tools for participant retention, payment management, travel, and trial budgeting, considerations for quality may include meeting specific needs, user-friendliness, or mobile application availability. 

This is especially critical, as nearly 90% of clinical trials fail for various reasons, including inability to maintain participant retention or difficulty managing payments, which are essential factors of clinical trials.

In the realm of clinical trial management, there is a growing emphasis on adapting to the tech-driven landscape. A commitment to quality is approached through values like collaboration, purpose-driven efforts, and problem-solving. These principles foster a culture of quality within the organisation, emphasising leadership, engagement, customer focus, process improvement, and evidence-based decision-making.

Excellence through leadership

The foundation for quality starts at the top with the leadership team. To ensure quality, investment in independent quality assurance and regulatory compliance teams should be made. Annual quality goals should also be established to encourage the process and ensure continuous improvements. 

An example of this includes annual training, focusing on concepts of quality by bringing quality to life for every employee by including a testimonial of a real user of the company's product or service, and the importance of the work that every individual who works there contributes to create a product/service that enhances, enriches, or diminishes the burden (aka beneficial use) in that consumer's day-to-day life. 

In addition, advanced training is conducted on investigative tools to develop robust corrective and preventive actions. A culture of collective responsibility promotes vigilance, focus, and continuous improvement, supporting both internal and external needs.

Customer-centric approach

In the context of trial management, a customer-centric approach involves prioritising understanding and support. Have teams solely dedicated to helping implement technology solutions, providing ongoing support throughout the study. 

Starting with a comprehensive understanding of requirements, the team guides stakeholders through the entire experience, showcasing tools that facilitate study setup, payment processes, and travel management.

Quality program and investigation process

Quality is embedded in policies, standard operating procedures, and work instructions. Internal audits and customer feedback are instrumental in identifying risks and assessing process effectiveness. A formal investigation process addresses quality issues, determining severity, root causes, and potential impact. This includes formal risk analysis and management tools to guide the process, ensuring corrective and preventative actions are taken.

Commitment to quality

A commitment to delivering consistent, high-quality processes and services is fundamental. Systems and procedures are designed to provide a seamless experience for all stakeholders involved in clinical trials. Success is gauged through positive feedback, compliance with relevant certifications and standards, and a dedicated focus on addressing challenges in retention and financial management collaboratively. The emphasis remains on supporting collective goals and problem-solving as a united team.

While quality remains subjective, when it comes to clinical trials, quality is critical. With these principles, we can foster a culture of quality for clinical trials across the globe.

Susan Shorter
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Susan Shorter
27 November, 2023