Business Architecture and
Clinical Trials

Improving efficiency in clinical trials...

By reviewing and redesigning the business architecture, the often fragmented legacy of processes can be reduced and management becomes more effective. In addition, accurate and foreseeing architecture is a good basis for innovation and growth. 

For the pharmaceutical clinical research process, nowadays, a lot of the architecture is fixed and is seen as the standard of the industry. It starts with a drug development plan and study designs and ends with regulatory submissions. The process includes a number of fixed, predefined process steps involving people who nearly know of each other’s existence. Due to this structure, decisions may be taken during the trial process that, from the overall business perspective, are unfeasible and unwanted. For some features of the drug development process, the current approach is regulatory required but in most cases it is just common practice based on insights of 20 to 30 years ago.

With the introduction of new ICT methods, the usage of real world data, and the increasing pressure on the drug market, it is possible and highly time to change the old-fashioned, time-consuming and costly step by step approach. Adaptive study designs, real world control arms and automatic source data collection are for example much more effective when standard ‘old-aged’ business-structures are redesigned. More aligned business processes and extensive knowledge management are key to the success of the new efficient clinical trial process.  

However, there is  no one size fits all  strategy that is efficient for the whole industry. By adapting to the business goals, its size, the client needs and their requirements, each business will have its own most efficient architecture. We like to find that together with you and to optimize your processes  by implementing and choosing the right tools, people and procedures in the right place.

Like to know more or to get a personal presentation of the tool? We are happy to share our ideas and thoughts with you. See our contact page directly or send an e-mail to