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. This requires transformative actions across all functions and new company-wide agile strategies are being implemented across the pharmaceutical and biotech industry.  
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.  
 Agile-working

 

 

 

A setup of a traditional trial management setup

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. Often, we see this structure leading to inefficient use of resources as team members are pulled into meetings and activities which are not part of their core competencies.  

Furthermore, trial team members are often involved in too many activities, many of which are not directly linked to their field of expertise. This is a waste of expertise, it leads to a lack of commitment and an inefficient use of the organization’s resources. 

 

 

 


Simplified overview of a proposed new trial management setup in clinical trial

The agile transformation brings opportunities  

Once you have decided to roll out agile transformation programs across your organization there is a real opportunity to also include the trial execution area, specifically the way we structure and set up trial management teams.

Picture-5

 

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

 

A proposed way to restructuring your trial management setup, which will lead to efficient use of resources and utilization of the right expertise at the right time, is to restructure your setup. 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 joint

    accountability 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 freeing 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. 

 


About the author

 

CWI (v4.00)

Christian Wittrup
Project Manager & Senior Consultant 

Christian specializes in analyzing and optimizing clinical processes, developing quality documentation, and implementing process improvements. Ensuring that projects runs according to plan, time and budget.

Prior to joining HERAX, Christian worked in a Lean project-oriented department for a global pharmaceutical company with strategic projects supporting management. During the last 5 years he has been deeply involved in projects spanning across the European continent. With a strong focus on how processes work and knowledge of the Trial Execution area Christian strives to ensure that processes, systems, governance and support is setup in the most optimal way.