I find myself back in the world of life sciences software after an absence of several years, and as with any return to a place of one’s memory, my reentry has sharpened my vision, revealing patterns I may have missed if I never left.

One thing I see is how clinical trial software has evolved with separate and distinct solutions for different aspects of managing clinical trials. There is Electronic Data Capture (EDC) for collecting trial data, Electronic Clinical Trial Management Systems (eCTMS) for planning and managing the trial, and electronic Trial Master Files (eTMF) solutions for managing trial documentation. And there many other solutions for enrollment, managing payments, and handling the actual medications.

But here is the question that jumps out at me:

Why have we evolved these distinct categories of trial management software?

Building Clinical Trial Software – The Old Way

Sometimes, the separations make perfect sense to me. When different users have different needs and work through different processes, good design says the applications they use should probably be separate.

But sometimes the dividing lines are based on differences in technology, not the needs of users. Specifically, there have evolved distinct and separate categories of software not based on the needs and roles of specific groups of users, but on the different types of information that you need to manage in a study.

Here is what I mean. EDC software is all about data: the information at the heart of the EDC solution is highly-structured data… that is, quantitative data, structured for analysis.

Conversely, the focus of eTMF solutions is on documents, not structured data, and there is a separate category of solutions for that area using document management technologies.   Additional solutions in the CTMS category focus on managing the schedules and processes of a trial.

Notice the way things evolved? One category for data, one for documents and one for the schedule and processes.

The lines of demarcation are not necessarily where they should be, and I think we are starting to see a “refactoring” of functions as different solutions evolve and reflect the needs of specific users in specific roles.

Building Clinical Trial Software for Users – The Right Way

We do not need to separate functions and activities because the type of information is different. We need applications that combine structured data and unstructured data, database rows and columns with metadata and workflow processes in easy-to-use interfaces designed around a user’s roles and tasks. Returning to the world of life sciences software with my sharpened vision, I am happy that this shift is happening. As I look at current eTMF solutions like Agatha’s, I see an application that combines the management of documents with a forms-based model that collects and stores structured information, and then adds workflow capabilities to define processes. In one system, a user can create and manage the documents that define the TMF but also manage the processes relating to the documents and collect and store structured data through forms-based entry.

Today, instead of a limiting factor, the technology available to us enables this ability to mix information types in an application. That’s because even though the regulatory authorities still require specific documents in specific formats, we can work with structured data to facilitate processes and reuse and then generate the documents from that data when we need them.

The ability to work in this way, with structured data, documents and other types of data, means that we can design better applications. And when I say better, I mean applications that reflect exactly the processes and activities of a specific set of users.

As this trend accelerates, I think we will see software solutions that increasingly group functions based on roles and tasks. These applications will be easier to use, resulting in users adopting them more quickly, which is essential given the economics of clinical trials.

And the best part is that we are just at the start of this shift. I realize we are at the dawn of a new generation of solutions that are more aligned with user roles, incorporating advanced AI technologies and adopt the best user interfaces.  It is an exciting time, and for me, it is good to be back 🙂

Interested in learning more about Agatha’s solutions? Drop me a quick email and we can chat.

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