Transform your trial management teams by setting them up for success

The industry is facing a continued need to demonstrate agility and optimization of their trial execution. All functions require transformative actions, and the pharmaceutical and biotech industry is implementing new company-wide agile strategies. Adopting these new agile strategies in the trial management area is challenging the way we used to work and requires a lot of thought on how to proceed.  

There is room for improvement 

We often see trial management teams structured as big groups of resources from all relevant functions. Each resource surely plays an important part at some point during the life cycle of a trial. This structure often leads to inefficient resource use as team members are pulled into activities outside their core competencies.

Involvement in numerous activities outside their expertise is a waste, leading to a lack of commitment and inefficient use of organizational resources among trial team members.

The agile transformation brings opportunities  

When implementing agile transformation, consider restructuring trial management teams for improved efficiency across your organization

Optimizing your trial management setup should see better utilization of resources and usage of knowledge.  

Proposing a trial management restructuring for efficient resource use and timely expertise utilization is recommended. The agile setup will allow your team members to be called upon when needed utilizing their core capabilities. A simplified way of looking at this is to divide your trial management setup into three pillars: 

  • The trial leadership is a dedicated small group consisting of representatives from major functions, e.g. Operations, Science and Biometrics. This team has the jointaccountability to move forward the execution of the trial.
  • Science leads the initial trial phases. Operations operates in the middle of the lifecycle by leading the conduct phases. Biometrics lead the analysis phases. After the conclusion of the analysis phases leadership transfers once again to operations who leads until close out. 
  • Experts are SMEs to a specific area or deliverable (e.g. selection of vendors or protocol creation) with the knowledge to quickly turn out the right product. 

Working groups are formed and closed as needed during the trial lifetime to tackle specific issues, obstacles, or deliverables. Forming working groups as needed will help free up resources. E.g. during trial conduct Trial Managers and CRAs will only be pulled in when needed and thereby allowing them to focus on their day-to-day operations and on what really brings value. 

The trial management setup will bring empowerment to the teams, foster agile discussions, simplify the governance and encourage faster decision making – ultimately bringing products quicker to market.  
Are you ready to hear how we can help you on your trial management journey? 

We have extensive experience in the trial execution area and actual experience in enabling the transformation from the old way of thinking trial management to a new way of working. Bringing empowerment to teams, easing the governance structure, and ultimately bringing products to market faster. 

We can assist you by combining a proven Life Science specific project methodology with a “best-in-class” knowledge of the trial execution area. 

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About the author

Allan Bech Thomsen
Project Director
Allan is a high-performance senior project manager, specializing in Program/Project Management, Program/Project Execution, Change Management, Business & IT Strategy Alignment, and Financial Management. Allan has been working in the Information Technology space for the last 30 years with deep involvement in the Trial Execution space for the past 8 years.