Building Customization into Innovative Clinical Trial Solutions

Building Customization into Innovative Clinical Trial Solutions 

As technology improves and embeds into clinical trials there are tools and methods that can be leveraged to enhance that technology as well as to enable solutions for specific trials using customization.  Customization is writing an application in a generalized manner that takes configuration values, generally from a database as inputs and using them, it controls the functionality of the application in some manner such as display, conditional logic or business logic that is unique to that trial. 

While customization can be powerful and can save time, before implementing it, determine if it is even appropriate for a particular use case. 

If the application will only be used for a single use case, there may not be any reusability. Consider doing a custom code application using more traditional methods because while customization has many benefits, there are still challenges including: 

• Takes more time than a single purpose application.  
• Needs to be carefully designed from the onset. 
• Requires coordination between development teams. 

However, the benefits for being able to reuse large parts of the codebase and only alter the configurations as needed are huge and include: 

• Allows the application to maintain a validated state longer, only configurations are changed. 
• Allows for quick changes when a clinical trial necessitates them. 
• Allows for quick prototyping of new setups. 
• Reduces additional work when adding new trials – scales much better than individual solution. 

Finally, the biggest benefit is that customization scales. More and more clinical trials can be added to the application with no code changes and only new configuration values.  

One example that illustrates these concepts is the web application framework used for internal reporting with SDC. This is used for generalized reporting within the company and the way it is designed is that two files are needed, the webpage file and the configuration file.  The webpage file is very basic and could be created by a first-year college student as all the complexity is abstracted in the configuration layer.  This file defines the interactive piece of the report and links it to the other pages within the existing web application.   

The powerful customization exists within the configuration file where the column headers, column data types, sorting, filtering, and conditional formatting are defined. The configuration file queries the database and retrieves the information, and the web page renders it. This means, in addition to those two files, the data needs to be populated in the database or the data warehouse. Assuming all this exists, a new page be created and rendered in less than an hour whereas a single use application could take ten times that amount of time. 

 In conclusion, if the application will be used more than once, using customization in software applications can have huge benefits from both a time savings perspective as well as a consistency perspective as all developers have a common framework to create new pages.  The fact that it stays in a validated state the whole time means less work for not only the development team, but teams overseeing the validation process can be freed up as well.  Customization in applications is time saver for everyone involved!