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How Balancing Agility with Consistency is Key in Clinical Trials

A clinical trial is a marathon- one that involves a multidisciplinary, often… MORE

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How Balancing Agility with Consistency is Key in Clinical Trials

A clinical trial is a marathon- one that involves a multidisciplinary, often global, team. From statisticians to regulatory affairs experts, each member of the clinical trials team has a vital role to play in the translation of a novel diagnostic tool, intervention or therapy to make a positive impact on the lives of patients.

While many hands make light work, such large and multi-faceted projects need a constant captain- someone who has oversight, someone to steer the project into the right direction, someone who has grown with the project and is intimately aware of its nuances.

In many projects, this much-needed captain is a role that is passed from person to person. These transitions are vulnerable to communication failures which, at best, result in inefficiencies, costing both time and money, as well as a leakage of unique accumulated experience and knowledge. This loss of knowledge can be particularly profound in clinical trials, where projects are complex and costly. At worst, these slippages can put the safety of volunteers and vulnerable patients at risk.

One way to avoid this risk is by maintaining consistency with project teams. At Neuroscience Trials Australia, we ensure that each project has a core team. Working across multiple functions, this core team is at the start and at the end of each project, providing stability and project-specific knowledge that is only gained over time and through experience.

Our teams are also adaptable, flexible and dynamic, and capitalise on the expertise of others in the organisation and of our broader clinical trials network. This dedication to teamwork and collaboration ensures our core team has the opportunity to test and develop fresh, new ideas. Our flat structure as an organisation means there are fewer functional layers, allowing us to be agile and responsive.

We also have infrastructure and protocols that strengthen the support systems for our work on projects. We use industry and world standard eTMF and CTMS project management tools, we have a Quality team that is fully integrated in the everyday of projects, we involve training of our staff in weekly meetings and at the start, during and after each project, and we always ensure there is the support of senior staff members on each and every project. Our lower staff turnover compared to the industry average is indicative of our strong support system, our collective passion for our work and our accumulated experience across hundreds of projects.

This is how we have the best of both worlds and we have found that combining a foundation of stability and consistency with agility and collaboration is the key to success in managing clinical trials.